Micro-fabricated Guidewire Devices Having Varying Diameters

ABSTRACT

Polymer catheters and guidewires for use in intravascular surgery, and more particularly polymer catheters and guidewires micro-machined with a micro-cutting machine to provide sufficient flexibility to travel through a patient&#39;s vasculature while retaining sufficient torquability to transmit torque from a proximal end to the distal end of the catheter or guidewire, and methods of producing the same.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/753,858, filed on Apr. 2, 2010 and titled “Micro-fabricated GuidewireDevices Having Varying Diameters,” which claims priority to and thebenefit of U.S. Provisional Patent Application Ser. No. 61/166,480,filed on Apr. 3, 2009 and titled “Catheters and Guidewires for use inIntravascular Surgery and a Micro-cutting Machine to Make/cut theCatheters and Guidewires,” U.S. patent application Ser. No. 12/753,858also being a continuation-in-part of and claiming priority to U.S.patent application Ser. No. 12/633,727, filed Dec. 8, 2009 and titled“Micro-cutting Machine for Forming Cuts in Products,” the entireties ofeach of which are incorporated herein by this reference.

BACKGROUND

The medical field utilizes highly flexible and torquable catheters andguidewires to perform delicate procedures deep inside the human body.Endovascular procedures typically start at the groin where a catheterand guidewire are inserted into the femoral artery and navigated up tothe heart, brain, or other anatomy as required. Once in place, theguidewire is removed so the catheter can be used for the delivery ofdrugs, stents, embolic devices to treat a variety of conditions, orother devices or agents. The catheter may be a balloon catheter used fortherapy directly, either by itself or with a balloon expandable stentpre-loaded on it. A radiopaque dye is often injected into the catheterso that the vessels can be viewed intraprocedurally or in the case of adiagnostic procedure, the dye may be the primary or only agent deliveredthrough the catheter.

Intravascular procedures, by definition, work in and with delicateanatomy, namely the vessels themselves, which are often also compromisedby disease. Damage to the vessels is particularly critical to avoid. Ifblood in the vessels is allowed to “leak,” direct damage can be causedto any tissue outside of the normal capillary approach contacted by theblood, and/or may result in a deadly problem of exsanguination or “bleedout”. When treating an aneurysm, the control of the catheter tip isespecially important. An aneurysm is a very fragile ballooned vesselwall which can easily be punctured if the guidewire or catheter is notprecisely controlled.

The guidewires and catheters produced with current technology machines(as described in published patents) have limited functionality. Anexample of such a micro-cutting machine is disclosed in U.S. Pat. No.6,014,919, issued to Jacobsen et al. on 18 Jan. 2000. Due to the singleblade design and other aspects of these existing machines, the machineslack the precision necessary to control small (sub 0.002″) features on areliable basis. They also lack the ability to precisely control andverify larger features, which could affect the safety and/or performanceof these devices.

These machines are also only capable of working with electricallyconductive stock material because the machines rely on the electricalconductivity of the stock material to determine the position of thestock relative to the cutting blade. Each cut made by the blade into thestock is based on the location of the electrically sensed surface of thestock and the pre-programmed depth of the desired cut.

Once a cut is made, the stock piece is rotated 180 degrees, the surfaceis sensed again, and another pre-programmed cut is made to a desireddepth. As the cutting machine is incapable of determining the precisediameter (at the location of the cut) of the stock material being cut,each cut is made according to a preprogrammed depth regardless of thatdiameter. This is a problem because stock material is not always of auniform shape and diameter—there are often imperfections along thelength of stock that can affect both the roundness of the stock materialand the diameter of the stock material at any particular location.

When the stock material is cut in the manner practiced by currentcutting machines, a small beam of remaining material, of varyingthickness, is formed by the sequential, opposing cuts. This beam isreferred to as a resultant beam. If the diameter of the stock is thickerthan anticipated at the location of the cuts, then the resultant beamwill be thicker and therefore less flexible than desired. If thediameter of the stock is thinner than anticipated at the location of thecuts, then the resultant beam will be thinner and therefore weaker thandesired. Thus, the critical dimension that governs both strength(safety) and flexibility (performance) is the width of the resultantbeam, which in current micro-cutting machines is not controlled directlyand is instead the result of two imprecise measurements—the measure ofthe relative distance between the blade and the stock material for thefirst cut and the measure of the relative distance between the blade andthe stock material for the second cut. Any imperfection in the surfaceof the stock material, or inconsistency in the diameter of suchmaterial, is directly translated to the resultant beam. This isproblematic in terms of both safety and performance of the finalproduct, whether it is a guidewire, catheter or other device. It isespecially critical when forming small dimension resultant beamsrelative to a larger dimension stock material, as an acceptabletolerance relative to the larger diameter of the stock material may beunacceptably large compared to the smaller dimension of the resultantbeam. Existing technology is also unable to cut any kind ofnon-conductive material, such as plastic. The existing cutting machinesrely upon electrical conductivity to sense the surface of the materialbeing cut and then make the cuts.

It would therefore be advantageous to create a micro-cutting machine formachining catheters, guidewires and other devices that utilizes twoblades to cut both sides simultaneously, that is able to directlycontrol the width of resultant beams, and that is capable ofmicro-cutting non-conductive material, such as plastic. Such a machinewould be faster, more predictable, and more versatile than currentmicro-cutting machines.

BRIEF SUMMARY

An embodiment of the invention is generally related to polymer cathetersand guidewires for use in intravascular surgery, and more particularlyrelated to various embodiments of polymer catheters and guidewiresmicro-machined with a micro-cutting machine to provide sufficientflexibility to travel through a patient's vasculature while retainingsufficient torquability to transmit torque from a proximal end to thedistal end of the catheter or guidewire, and methods of producing thesame.

An embodiment of the invention is generally related to hybrid cathetersand guidewires for use in intravascular surgery, and more particularlyrelated to various embodiments of hybrid catheters and guidewiresmicro-machined from two or more stock materials with a micro-cuttingmachine to provide sufficient flexibility to travel through a patient'svasculature while retaining sufficient torquability to transmit torquefrom a proximal end to the distal end of the catheter or guidewire, andmethods of producing the same.

An embodiment of the invention is generally related to catheters fortransporting relatively high pressure fluids through a patient'svasculature, and more particularly related to catheters micro-machinedso as to avoid penetrating a lumen wall of the catheter so as topreserve the fluid pressure integrity of the catheter without inclusionof a flexibility hindering liner tube, and methods of producing thesame.

An embodiment of the invention is generally related to stabilizing thetorque transmission of a micro-cut catheter or guidewire while thecatheter or guidewire is under flexing strain, and more particularlyrelated to utilizing elastomer laminate to stabilize the micro-machinedstructure so as to avoid deformation while under flexing stain andthereby reliably transmit torque to a distal end of the catheter orguidewire.

An embodiment of the invention is generally related to catheters fortransporting relatively high pressure fluids through a patient'svasculature, and more particularly related to an apparatus for andmethods of utilizing an elastomer laminate to fill fenestrations in amicro-machined skeletal structure, thereby re-establishing fluidpressure integrity of the catheter's lumen without use of a flexibilityhindering liner tube.

An embodiment of the invention is generally related to hybrid laminatedcatheters and guidewires for use in intravascular surgery, and moreparticularly related to a soft tip configuration for use with variousembodiments of catheters and guidewires to provide a gradual stiffnesstransitioning towards the distal end of the catheter or guidewire and toprovide a shapeable tip that a surgeon may custom bend to fit aparticular procedure or a particular patient's vasculature.

An embodiment of the invention is generally related to guiding cathetersfor carrying large volumes of high pressure fluid deep into a patient'svasculature, and more particularly related to a micro-cut polymerguiding catheters with a shapeable soft tip that is sufficientlyflexible to travel through a patient's carotid siphon while alsoretaining sufficient torquability to smoothly and reliably transmittorque through the entire length of the catheter.

An embodiment of the invention is generally related to a hybrid catheterhaving an outer diameter at its distal end that is larger than the outerdiameter at its proximal end.

An embodiment of the invention is a torqueable hub having abarrel-shaped body with a plurality of longitudinal groves formedtherein. The hub includes an axial interior space within which a syringecan be inserted.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the prior art components of a catheter and/orguidewire system;

FIG. 2 illustrates a general overview of a micro-cutting machine in anembodiment;

FIG. 3A illustrates a partially cut-away, plan view of a cuttingassembly of the micro-cutting machine of FIG. 2 in an embodiment;

FIG. 3B illustrates a cross-sectional view of a piece of cylindricalstock material resting within a feed trough of the cutting assembly ofFIG. 3A in an embodiment;

FIG. 4 illustrates a desktop image generated by the imaging system andCPU of FIG. 2 depicting the stock material once it has been cut by thecutting assembly;

FIG. 5 illustrates the imaging system of the cutting assembly of FIG. 2;

FIGS. 6A, 6B and 6C illustrate different views of a product cut inaccordance with an embodiment;

FIGS. 7A, 7B and 7C illustrate cross-sectional views across and alongthe length of pieces of cylindrical stock material cut to form differentproducts, while FIG. 7D illustrates just a cross-sectional view across acatheter, all in accordance with an embodiment; and

FIGS. 8A and 8B illustrate a prior art lumen forming stock material anda prior art resultant beam cut into a lumen forming stock material;

FIG. 9 illustrates a cross-sectional view of a micro-cut catheterwithout fenestrations in accordance with an embodiment;

FIG. 10A illustrates a prior art exemplary deformation of a ring of amicro-cut guidewire;

FIG. 10B illustrates an elastomer laminate applied to a micro-cutguidewire in accordance with an embodiment;

FIG. 11 illustrates an elastomer laminate utilized to restore fluidpressure integrity to a micro-cut catheter in accordance with anembodiment;

FIG. 12 illustrates a soft tip configuration for a micro-cut catheter inaccordance with an embodiment; and

FIG. 13 illustrates a torqueable hub in accordance with an embodiment.

FIG. 14A illustrates a guidewire device in accordance with one or moreembodiments.

FIG. 14B illustrates a guidewire device in accordance with one or moreembodiments.

FIG. 14C illustrates a guidewire device in accordance with one or moreembodiments.

FIG. 14D illustrates a guidewire device in accordance with one or moreembodiments.

FIG. 15A illustrates a catheter device in accordance with one or moreembodiments.

FIG. 15B illustrates a catheter device in accordance with one or moreembodiments.

DETAILED DESCRIPTION

The herein disclosed embodiments of catheters and guidewires utilizepreviously unavailable combinations of materials and configurations toachieve superior levels of performance during surgical procedures.Several variations of micro-catheters, guiding catheters, and guidewiresare described herein, as well as more general techniques that canimprove the performance of any of these types of medical devices. Amicro-cutting machine utilized to precisely cut cylindrical stockmaterial used to form the catheters and guidewires is also disclosed.

FIG. 1 illustrates the prior art components of a catheter and/orguidewire system 10. For ease of explanation and use herein, and whenappropriate, catheters and guidewires will be referenced herein asproducts. The overall length of the product system 10 is typically 175centimeters to 195 centimeters in length, and can be as long as 300centimeters for more difficult procedures that must travel furtherwithin the human body. The proximal end 11 of product system 10 is theend that a surgeon or medical professional holds during a surgicalprocedure. Proximal end 11 may include an attached handle structure,which is referred to as a torquer 12. Torquer 12 is gripped by thesurgeon and physically rotated, which is referred to as torquing theproduct, with the intent to rotate the opposite end of the product,which is known as the distal tip 13.

Distal tip 13 may be bent slightly, either by the surgeon himself justprior to surgery or during production by the product manufacturer.Distal tip 13 is bent so that when product system 10 is physicallyrotated, or torqued, the bent tip also rotates and thereby points in adifferent direction—allowing the surgeon to torque the distal tip 13into the desired vasculature pathway. The portion of the length ofproduct system 10 nearest the proximal end 11 is referred to as proximalportion 14, and the portion nearest the distal tip 13 is referred to asdistal portion 15. The precision cut products disclosed herein provideenough flexibility to allow easy navigation throughout a patient'scomplex vasculature while retaining enough torquability to smoothlytransmit the surgeon's torquing movements from torquer 12 to distal tip13. The guidewire 16 can be inserted into the hollow central portion ofthe catheter and may be thought of as being comprised of the samesegments as the catheter, with a distal tip, a distal portion, aproximal portion, a proximal end, and possibly a torquer.

As discussed in the Background section, prior art machines for producingcatheters and guidewires have severe drawbacks that limit the types ofmaterials that may be machined into catheters and/or guidewires and thetypes of products that can be produced. As such, the discussion of theherein disclosed precision cut products will begin by describing amicro-cutting machine that is capable of machining a much wider array ofmaterials, at a much wider array of dimensions while conforming to thestrict tolerances required of delicate medical procedures. For example,polymer (plastic) stock material such as PEEK (polyetheretherketone) canbe micro-machined on the micro-cutting machine described below into ahighly flexible catheter at a relatively large diameter, whereas polymermaterial was previously impossible to machine because of itsnon-conductive qualities. In another example, stainless steel stockmaterial can also be micro-machined on the micro-cutting machinedescribed below into shapeable guidewires, whereas stainless steel waspreviously impossible to machine because it's relatively high stiffnesswould require the beams to be cut so small (about 0.002 inches) that theresulting product would not be functional. One or more micro-cuttingmachines capable of machining non-conductive stock materials, as well asother stock material at previously impossible manners will now bedescribed.

FIG. 2 illustrates a general layout of the micro-cutting machine inaccordance with an embodiment. Micro-cutting machine 101 includescutting assembly 140, which generally has at least a pair of blades orcutting members and two or more stock material controllers, includingfeed and rotate motors, for precisely advancing and controlling theangle of the cylindrical stock material as it is cut and then preparingfor a next cut. Cutting assembly 140 will be explained in much moredetail below. Communicatively connected to cutting assembly 140 areelectronic controllers 110 (which may be one or more electroniccontrollers, which are referred to as an electronic controller unit) forproviding precise control signals to the cutting assembly 140 to controlthe position and speed of the blades and the position and angle of thestock material. The electronic controllers can also control the lightsand a camera (an imaging system) for imaging the stock material beforeand after cuts and collecting data generated by the imaging system. Acentral processing unit 130 (such as a personal computer that includes adisplay, input and output systems, a storage system, etc., or some othertype of CPU) receives user input, controls the electronic controllers110 and the cutting assembly 140, and processes data generated by theimaging system to adjust the relative gap distance between the twoblades. Alternatively, the CPU 130 could communicate directly with theimaging system and bypass the electronic controllers 110. A power supply120 supplies power to at least the cutting assembly 140, and possiblyother components of the micro-cutting machine 101.

FIG. 3A illustrates a plan view of an embodiment of cutting assembly140, which is mounted on a stationary frame assembly 200. The stockmaterial 202 is fed into the cutting assembly 140 by the feed motorassembly 204, which can hold the stock material in a fixed positionrelative to the X-axis, the direction parallel to the spindle 206, andwhich can move the stock material along the X-axis by very small,controlled increments, so as to appropriately feed the stock material202 into the cutting assembly 140, as further discussed below. The feedmotor assembly 204 may comprise two feed motors (not separately shown),one for gripping the stock material 202 while it is being cut, asfurther described below, and one for moving the stock material 202 alongthe X-axis when the stock material 202 has been released by the firstfeed motor.

The stock material 202 shown in FIG. 3A is not illustrated as its actualsize. The outer diameter of the stock material 202 can be 0.030 inchesor less, or about 3 French on the French catheter scale, where a Frenchis equal to three times the outer diameter of the stock material 202measured in millimeters. Converting to inches, 3 French is equal to0.039 inches, 4 French is equal to 0.053 inches, 5 French is equal to0.066 inches, 6 French is equal to 0.079 inches, etc. Accordingly, basedon the relative size of the cutting assembly shown in FIG. 3A, even alength of 6 French stock material 202 would be so small as to be almostimpossible to see clearly, so the stock material 202 illustrated in FIG.3A is much larger than its actual size for purposes of this illustrationonly.

The feed motor assembly 204 is mounted on a spindle 206 that issupported within the bearings of a bracket 208 mounted to the stationaryframe assembly 200. A pulley 210 mounted to the spindle 206 is driven bya belt (not shown) that is, in turn, connected to another pulley (notshown) below the pulley 210, which is connected to a rotational motor(not shown) mounted within the stationary frame assembly 200. Therotational motor is a stepper motor, or the like, that is capable ofextremely precise computer-controlled movement. Based on programmingprovided through the electronic controllers 110 and the CPU 130 (such asthrough a user interface that allows a user to change certain parametersof operation of the electronic controllers 110 and therefore variouscomponents of the cutting assembly 140), the rotational motor can beprogrammed to cause the pulley 210 to rotate a specified number ofdegrees, so as to rotate the spindle 206 and feed motor 204 by the samespecified number of degrees. Hence, the entire feed motor assembly 204rotates, along with any gripped stock material 202 when the pulley 210and spindle 206 are rotated by the rotational motor. Alternativeembodiments could include different arrangements of the feed motorassembly 204 and the rotational motor, such as a feed motor assemblythat only moves the stock material 202 along the X-axis and a rotationalmotor that grips and turns the stock material 202 when it is not beingfed along the X-axis.

In order to better illustrate the relationship between the variouscomponents of the cutting assembly 140, the stock material 202 is shownexiting the feed motor assembly 204 supported by an elongated feedtrough 212, which extends from the feed motor assembly 204 to one sideof the cutting area (where the stock material 202 is cut by the blades214, as further described below), and then extends from the other sideof the cutting area to an output area 216. In reality, the length of thefeed trough 212 between the feed motor assembly 204 and the cutting areawould be relatively short. This enables the feed motor assembly 204 tobe much closer to the cutting area, such that the stock material 202would be cut almost immediately upon exiting the feed motor assembly204. Keeping the length of the stock material 202 short between the feedmotor assembly 204 and the cutting area helps to better control thestock material 202 while it is being cut, i.e., preventing the stockmaterial 202 from moving along the Y-axis, the direction perpendicularto the spindle 206, or rotating while the stock material 202 is beingcut.

It should also be noted that most of the stock material 202 is likely tobe substantially rounded in shape, although other shapes could also beused. The stock material 202 has both width and height, giving it aY-axis and Z-axis position, where the Z-axis is vertical to a planeincluding the X-axis and Y-axis. The feed trough 212 is intended topassively guide the stock material 202 as it is moved along the x-axis,which it could do in many different ways, such as through theutilization of precisely located guide posts or elongated members or aguide path that maintains the stock material 202 in a desired positionrelative to the Y-axis and Z-axis. The guide path of the feed trough 212for rounded stock material 202 is preferably V-shaped, as illustrated bythe cross section shown in FIG. 3B, wherein the stock material 202 liesin the bottom of the point formed by the V-shaped guide path within thefeed trough 212.

As noted above, the cutting area is defined by a small gap between thetwo sections (prior to and after the cutting area) of the feed trough212 where a pair of opposing blades 214 cut the stock material 202. Inan embodiment of the application, the two blades 214 can be eithersemiconductor dicing blades or standard “tooth” type blades formed of acarbide material, such as tungsten carbide, to improve wear resistance.The submicron grain size of tungsten carbide and similar compositesworks well because they are less brittle, extremely hard, and canmaintain their sharpness even at very small blade thicknesses. In anembodiment, additional different types of cutting instruments andsystems could be utilized in place of the blades 214, such as water jetcutting systems, flame or oxyfuel cutting systems, plasma (arc) cuttingsystem, electric discharge machining (EDM), etc., although not all ofthese systems are appropriate for use when cutting non-metal stockmaterial or even certain types of metal stock materials, such as softermetals and less conductive metals. Given the variable operation of suchadditional types of cutting systems, it may also be necessary and/ordesirable to change the orientation of the cutting assembly 140 and/orthe stock materials 202 so instead of bringing the cutting point of theblade or system down along the Z-axis, the cutting point may be moved inthe X-axis, or the cutting point may be held stationary while the stockmaterials is moved relative to the cutting point. All such alternativecutting systems are anticipated herein. Hence, when reference is madeherein to a “dual blade” system, it is to be understood that any type ofalternative cutting member or cutting system could also be used,depending on the application involved.

An embodiment for cutting plastic utilizes a tooth type blade withapproximately 56 teeth. When cutting PEEK (polyetheretherketone) andother plastics with this blade type, a blade thickness of approximately0.006 and 0.008 inches works well. When cutting nitinol, stainless steeland other hard metal and composite materials, a diamond semiconductordicing blade with a thickness of approximately 0.002 inches works well.Given such thickness, the size of the open cutting area between the twosections of feed trough 212 represented in FIG. 3A is not to scale andis exaggerated in size in order to more clearly illustrate the openingof the cutting area. Of course, the blades 214 shown in FIG. 3A appearto be much larger in diameter than they really are as well, especiallysince, in most cases, they are only required to make very shallow cutsin the stock material 202. Since the stock material 202 could be formedof any type of material having any size diameter, such larger stockmaterial would obviously need to be cut with thicker blades havinglarger diameters than those used to cut guidewires and catheters.

As will be further noted below, the embodiment does not require thestock material 202 to be of a metallic composition so its location canbe electrically sensed by the blades 214 before a cut can be made. Theembodiment can be used to cut any type of material, whether metallic ornon-metallic, such as PEEK, a semi-crystalline, high temperaturethermoplastic that is ideal for use in catheters due its high modulus ofelasticity resulting in torqueability and the ability to hold a shape,and combinations of metallic and non-metallic materials. Although thegeneral belief in the art has been that lower cutting speeds werenecessary, especially when cutting PEEK, to reduce spur generation inthe area of each cut, this was found not to be the case; much higherrotational speeds of the blades 214 worked well to reduce spurgeneration and provide exception accuracy. The embodiment also cutsother materials, including stainless steel and metallic composites atvery high speeds with no burrs and with exceptional accuracy.

The blades 214 are located within a blade enclosure 218 (shown withoutits top in FIG. 3A so the interior can be viewed) through which air canbe pumped to cool the blades 214 and the stock material 202, and throughwhich debris cut from the stock material 202 can be removed. The hoses220 of the air handling system can be used for pumping air and/orvacuuming air from the blade enclosure 218. The blades 214 can also bewater cooled, as is known in the art.

In order to drive the blades 214 directly at higher speeds withoutrequiring more expensive motors and added additional complications, eachof the blades 214 is attached to a spindle 222, that is orientedparallel to the X-axis. Each of the spindles 222 is driven by a belt 224that is rotated by a pulley attached to the spindle motor 226. Thespindle motor 226 is program controlled through the electroniccontrollers 110 and the CPU 130. The blades 214 are driven indirectly inthis manner so as to achieve greater rotational speeds than would bepossible or practical with a direct drive arrangement. For example, thespindle motor 226 is capable of running at approximately 4,000revolutions per minute (rpm) over an extended period of time withoutstressing the spindle motor 226 or any of the bearings supporting thepulley. The aspect ratio between the pulley and the spindle 222 isapproximately 6:1, so the slower rotating spindle motor 226 is capableof rotating the spindle at approximately 24,000 rpm, the desired speedfor cutting PEEK and other materials. A direct drive motor capable ofoperating at 24,000 rpm would be significantly more expensive, requiredifferent bearing assemblies, and likely have a significantly higherfailure rate.

The combination of the blade 214, the spindle 222, the spindle motor 226and pulley, and the belt 224 is referred to herein as a “cuttingassembly”, but the same term would apply if a different cutting systemwithout blades was being used as well. Each cutting assembly is attachedto a blade stepper motor 228 that controls the Y-axis location of eachblade 214. The stepper motors 228 are mounted on a movable frameassembly 230, as further described below. Each of the stepper motors 228are program controlled through the electronic controllers 110 and theCPU 130, or can be manually adjusted through the control knobs 232.

To cut a piece of stock material 202 so as to leave a resultant beam, asfurther described below, of a specified dimension, each of the steppermotors 228 are adjusted to a predetermined location such that the blades214 are close but not touching, and a cut is made in the uncut stockmaterial 202 with both blades at the same time. The manner in which bothblades cut the stock material 202 simultaneously is further describedbelow. Once the cuts are made, the resultant beam is measured todetermine if it is of the desired dimension. The stepper motors 228 arethen adjusted along the Y-axis to move the cutting assemblies inwardtoward each other or outward away from each other, and another cut ismade to the uncut stock material 202. This process is continued untilthe desired resultant beam dimension is achieved, at which point aseries of cuts in the uncut stock material 202 is carried out.

By mounting the cutting assemblies on the stepper motors 228, it ispossible to precisely control the Y-axis location of each blade 214 andto accommodate a larger variety of different stock materials 202, suchas raw wire, tubing, and other shapes and sizes of cylindrical stockmaterials 202. For example, if a wide diameter catheter is to be cutfrom a relatively wide diameter piece of tubing, the stepper motors 228can move the cutting assemblies apart to accommodate the larger thannormal stock material. In another example, it may be that a user wishesto micro-cut a piece of metal wire for a guidewire having 0.002 inchresultant beams at one end and 0.004 inch resultant beams at theopposite end, with a gradual transition between the two beam widths. Inthis example, the stepper motors 228 can be precisely controlled byelectronic controllers 110 and processor 130 to position the blades 214to make cuts resulting in the desired resultant beam width, whether thatbe 0.002 inches, 0.0025 inches, 0.003 inches, 0.004 inches, etc. Thus,almost any desired dimension can be machined at any specified location.

Both of the cutting assemblies and the stepper motors 228 are in turnmounted on the movable frame assembly 230, which is moved up and downalong the Z-axis by a Z-axis motor (not shown) located within themovable frame assembly 230 and mounted on a non-visible portion of thestationary frame assembly 200. By mounting the cutting assemblies andstepper motors 228 on the movable frame assembly 230, it is possible toprecisely control the Z-axis position of both blades 214 at the sametime. The blade enclosure 218 can be designed to be mounted to themovable frame assembly 230, such that the blade enclosure 218 movesalong with the blades 214, or blade enclosure 218 could include twoslots within which the spindles 222 could move up and down apart fromthe blade enclosure 218. So as to better seal the interior of the bladeenclosure, it is preferable to have the blade enclosure 218 move withthe blades 214.

Also shown in FIG. 3A (by dotted lines so that underlying components arevisible) is the imaging system of the embodiment, which primarilycomprises a digital camera 234 mounted within an upper cowl 236 andupper and lower lights, not shown. The upper cowl 236 is mounted to thestationary frame assembly 200 so that the camera 234 does not move alongthe Z-axis as the blades 214 move. The camera 234 is positioned directlyover the cutting area and is focused on a portion of the stock material202 as it is being cut and just after it has been cut, as furtherillustrated in FIGS. 4 and 5.

The camera 234 could be any of a number of commercially availablehigh-speed digital video cameras as long as it is capable of capturinghigh quality pixilated video image data. In an embodiment, the camera isa model AM-413T digital microscope camera, manufactured by SunriseDinoof New Hyde Park, N.Y. The more interesting aspects of the imagingsystem are the manner in which the stock material 202 is backlit andilluminated in order to increase contrast around the edges of the cutstock material 202 and how the digital image processing is capable ofprecisely measuring both cuts and the resultant beams.

FIG. 4 is an illustration of a desktop image 300 generated on thedisplay of the CPU 130. The desktop image 300 includes an imaging window302 and a control window 304. The imaging window 302 displays digitalvideo images of the stock material 202 as it is being cut and as it isbeing measured by the imaging system. The area 306 shows the stockmaterial 202 just after it has been cut by the blades 214 and the blades214 have moved beyond the focused view of the camera 234. The stockmaterial 202 being cut in the example illustrated in FIG. 4 is a tubeused to make a catheter that is being rotated ninety degrees (90°) aftereach cut. Once a cut has been made, holes 308 are formed in the walls ofthe stock material 202 that become visible as the stock material 202 isturned in order to make the next cut. As the stock material 202 advancesalong the X-axis of the cutting assembly, the stock material 202 passesin front of a backlight, illustrated by the circle 310.

Referring briefly now to FIG. 5, the camera 234 of the imaging system400 is placed directly over the top of stock material 202, so that itmay image and measure the stock material 202 and the resultant beam 314formed by the two cuts. As discussed above, feed trough 212 leaves a gapthrough which the blades 214 can pass. The backlight 410 is an opticalfiber, or a bundle of several optical fibers, through which red LEDlight 420 is provided by the imaging system. The optical fiber providingthe backlight 410 is passed through a separately drilled hole (notshown) that enables the backlight 410 to shine around the stock material202 and be visible to the camera 234. The backlight 410 is held in placebelow the cutting area by an anvil that is affixed to the stationaryframe assembly 200 and is positioned to illuminate the stock material202 just after it has been cut, although the stock material 202 can alsobe seen in imaging window 302 just as it is being cut. Camera 234 iscommunicatively coupled to processor 130 (not shown in FIG. 5) in orderto provide feedback while the stock material 202 is being cut, and inorder to store one or more images of one or more resultant beams 314.

A set of one or more green and blue LEDs 430 can be positioned above thestock material 202 and around the camera 234 to provide additionallighting 440 for a user to see the top side of the stock material formanual inspection purposes. The combination of a red backlight 410 andthe green and blue LEDs 430 was selected because the camera 234 providesthree color image channels of image data (red, green and blue) and theseparately colored lighting enables the image data to be easilyseparated. The CPU 130 (and the software it operates) receiving theimage data uses the red image channel for edge detection because itprovides a high-contrast back lit image of the cut with no front sidereflections that would confuse the measurement software being utilizedby the CPU 130 to measure each cut. The green and blue image datacreated by the green and blue LEDs 430 and the camera 234 aretransmitted through the green image channel and the blue image channel,respectively.

A purpose of the imaging system 400 is to monitor the exact location andsize of cuts formed in the stock material 202. This information, meaningthe image of a cut and resultant measurements, can be used in a numberof different ways. For example, the images can be used to validate theaccuracy and repeatability of the micro-cutting machine at or near intime to when the stock material 202 is being cut. If the images arebeing analyzed on the fly—while in the process of making the many cutsnecessary to transform a piece of stock material 202 into a catheter orguidewire—the imaging system 400 can be used to stop production on thatpiece if a cut goes awry or the stock material 202 is out of tolerance.

Returning now to FIG. 4, although the camera 234 could theoreticallycapture an image of every single cut made to the stock material 202,doing so would generate an excessive amount of data that could not becompetently reviewed at a reasonable cost by human operators. Instead,so as to provide adequate quality control, images are captured andrecorded on a periodic or random (randomized test sampling protocol)basis, as further described below. While an image of the stock material202 is being captured, as illustrated in FIG. 4, two visual overlays 312are applied by the imaging system to the image data within the back litarea 310 to determine the length of each cut and the resultant beam 314,which is referred to as the “web” in FIG. 4. The overlays 312 measureacross the stock material 202 at two or more different points, includingat least the width or thickness of the stock material 202 and the widthof the web or resultant beam 308.

The measurements taken by the overlays 312 are then analyzed by the CPU130 and utilized to determine the length of the left cut, the right cutand the resultant beam or web 314. For example, by pre-determining thenumber of pixels per unit of measurement in the image being captured,and then counting the number of pixels displayed in the image data forthe length of an object to be measured (using real-time image processingsoftware operated by the CPU 130), it is possible to determine accuratemeasurements from the image data alone, without having to make use ofmechanical measuring means. For example, if it is known that a piece ofstock material 202 to be cut should have a width of 0.039 inches and theimage data has a pixilation of 500 pixels per 0.05 inches, thenapproximately 390 pixels correspond to the width of the stock material202. If a cut is then made in the stock material 202 from both sidesleaving the resultant beam 314, and that resultant beam 314 is measuredat 359 pixels, then the resultant beam 314 has a width of 0.0359 inches.Similar measurements can be made of each cut in the stock material 202and these real-time measurements can then be displayed at 316 so theprogress of the cutting operation can be monitored by an operator or theCPU 130.

When the width of the stock material 202 at the point of a cut isthicker or thinner than expected, the resultant beam 314 will still bewithin an acceptable range of its normal size because the position ofthe blades 214 relative to the stock material 202 is largely based onthe centered position of the stock material 202, versus the knowntechnique of basing each cut on the relative difference of the separateblades to the side of the stock material each blade is responsible forcutting. Hence, when thicker stock material 202 is cut, more stockmaterial is cut away and when thinner stock material 202 is cut, lessstock material is cut away, but in each case leaving a resultant beam ofthe desired size, versus generating thicker or thinner desired resultantbeams, as is common in the art.

The control window 304 displays each measurement in a log section 318 ofthe control window that can be scrolled. As illustrated in FIG. 4, theCPU 130 has been programmed to instruct the imaging system to capture animage and measure the left cut, the right cut and the web on a periodicbasis. For example, the first cut shown was grind 995 that resulted in aleft cut (CUTL) of 0.0018 inches, a right cut (CUTR) of 0.0013 inches,and resulted in a web of 0.0359 inches, as noted above. The measurementsand image file for grind 995 is then stored in a data file labeledA_133.JPG. The grinds being recorded do not necessarily correspond tothe same number of cuts that have been made, as more or less cuts may bemade than are imaged, measured and recorded. Hence the steps illustratedas part of the log section 318 may correspond to a separate programmedprocess that keeps track of the number of cuts that have been made.

The control window 304 also includes selectable buttons 320 that allowan operator to stop or pause a job or start and stop the cuttingprocess. The operator also has the option of assigning a title to eachcutting job and to store the data associated with that cutting job in aparticular folder on the CPU 130.

As previously noted, the CPU 130 provides programmed control of theelectronic controllers 110, the rotational motor and the feed motorassembly 204 to control the movement of the feed stock 202 into thecutting assembly 140 along the X-axis. Once the stock material 202 hasbeen fed into the cutting assembly and gripped by the feed motorassembly 204, the CPU 130 would instruct the rotational motor either toleave the stock material 202 at its current orientation or to rotate itby some degree specified by the CPU 130. Once the stock material 202 hasbeen cut, the feed motor assembly 204 would advance the stock material202 by some specified amount along the X-axis to position it for thenext cut and grip the stock material 202. The rotational motor wouldthen rotate the feed motor assembly 204 and the stock material 202 wouldbe cut again. This process would then be repeated until all of the stockmaterial 202 has been cut as desired.

By rotating the stock material 202 between each cut, the cuttingassembly 140 can generate a cut stock material 202 with resultant beams314 that are not all aligned in the same orientation along the length ofthe micro-machined product. For example, the stock material 202 could beturned ninety degrees from its angle at the time of the last cut, ormany variations thereof, such as turned five or more degrees short ofninety degrees (i.e., 85 degrees) from the angle of the last cut, oreven cut at random angles relative to the angle of the last cut.

An additional feature of the embodiment is the ability to measure thestock material 202 prior to being cut and using the resultantmeasurement to guide the depth of cuts. If stock material 202 wasassumed to be 0.039 inches in diameter and it was desired to create aresultant beam 314 having a thickness of about 0.008 inches, then eachcut would need to be 0.0155 inches deep. If the imaging systemdetermined that the stock material 202 was only 0.032 inches in diameterinstead of 0.039 inches, then the cutting machine would know that itneeded to reduce the depth of each cut to 0.012 inches so as to leavethe desired resultant beam 314 of 0.008 inches. However, as noted above,this is not necessary with respect to the embodiment where two blades214 cut down from opposite sides of the stock material 202 because oncethe relative gap between the blades 214 has been established (that isrelative to the cutting points of the two blades 214 or other cuttingmembers), the gap dictates precisely the resultant beam 314 regardlessof the outside diameter of the stock material 202. While the amount ofmaterial, or “depth of cut” is indeed different, there is no differencein the resultant beam 314 width.

In certain cases, however, it may be desirable to operate the blades 214in an “offset cut” mode, wherein the blades 214 are not aligned in thesame plane and deeper cuts are made. In this case, the cuts appear asindependent cuts from each side (although cut simultaneously). The depthwould then be important as each resultant beam, and the flexibility andstability of this type of structure, would be determined by the distancefrom the end of the cut to the opposing side of the tube. Although thistype of structure could be made using the embodiment, it may not beterribly practical since it would require the cutting machine to imageand measure the stock material 202 before each cut was made and toadjust the stepper motors 228 on the fly in the event it was determinedthat the stock material 202 was of the wrong diameter in order to changethe depth by which the cuts are made.

Accordingly, the embodiment presently relies upon a quality controltechnique that measures only some of the cuts after they have been madeinstead of every cut. This enables the system to monitor the quality ofthe stock material 202 and other aspects of the system, but does notnecessitate changing how the system is operating from cut to cut. Forexample, in the event stock material 202 was out of specification, it isnot likely that its diameter would only vary at a single isolated point.Rather, if stock material 202 was out of specification at one point, itwould likely be out of specification along of a length of the materialor be out of specification at multiple individual points, one or more ofwhich would be detected through the quality control technique. Largevariations in the diameter of the stock material 202 may make the stockmaterial undesirable for certain applications, so if this wasdetermined, the cutting assembly 140 could be stopped and the productdiscarded once detected.

As stated, a main purpose of the micro-cutting machine is to make pairsof cuts (but not necessarily opposing) on cylindrical stock material toform flexible and torquable products, such as guidewires, catheters andother similar types of devices, all referred to herein as “products”.While it is known in the art to create a flexible and torquableguidewire and catheter by making a single cut with a blade into a sideof a cylindrical piece of stock material (metal wire and/or tubing), andthen rotating the material and making an opposing cut on the oppositeside of the stock material with the same blade. When this process isperformed along all or part of the length of the stock material, thediameter of the stock material is reduced in numerous places, whichincreases the flexibility of the resulting product, but since theproduct retains the same overall outside diameter, the resulting productis able to retain much of its torquability. While the stock material cutin this fashion is usually cylindrical, since the cuts are made fromopposing sides or nearly opposing sides toward the middle, it is helpfulto think of the stock material as having a first side and a second side,even though in reality the stock material is substantially round and hasonly a single side.

FIG. 6A illustrates the resulting beams that are generated by circularblades that cut from a first side and then a second side, a resultingbeam that can also be generated through utilization of the embodiment.FIGS. 6B and 6C illustrate resulting beams that can only be generatedthrough utilization of the embodiment. A cross-sectional view of solidstock material 202 is shown in FIGS. 6A, 6B and 6C. Based on existingtechnology, when the solid stock material 202 has been cut on the firstand second sides (either all at once, as is presently disclosed, or onthe first side and then on the second side, as is known in the art), aresultant beam 510 would remain. This type of resultant beam 510 isknown in the art as a radius cut beam because it tapers from thecircumference to the center point. Existing technology cuts the solidstock material 202 by advancing toward the solid stock material 202along the Y-axis described above. As a result, the circular blade cutsthe stock material 202 further in the central area than it can on theouter areas, always resulting in the radius cut beam 510.

Although a radius cut beam 510 is appropriate for some uses, it is notideal from a torquability and safety perspective. The reduced thicknessof the central area of the radius cut beam 510 enables stress to buildup in that area as the product is twisted, which can result in breakageof the product. Given that products are often used in intravascularprocedures, any breakage is highly undesirable. Likewise, if there isany irregularity in the diameter of the product, which irregularitycannot be sensed by the cutting machine, the cutting machine will make acut in the product based on its programming alone. Hence, using theexample provided above, if a guidewire was 0.039 inches in diameter andit was desired to create a resultant beam having a thickness of about0.008 inches at the central area, then each cut would need to be 0.0155inches deep. If the guidewire, however was only 0.032 inches in diameterand the cutting machine used electromagnetic sensing, instead ofreal-time imaging, then each side would still be cut by 0.0155 inches,leaving a resultant beam of 0.001 inches, which would also likely resultin breakage when inserted into a simple curve.

The presently disclosed cutting machine, however, operates by moving thedual blades 214 along both the Y-axis and the Z-axis and is capable ofcreating a variety of differently shaped resultant beams, including theradius cut beam of FIG. 6A, as well as the straight cut beam of FIG. 6Band the convex cut beam of FIG. 6C. To create the straight cut beam, thecutting assemblies are moved above the stock material 202 along theZ-axis and adjusted along the Y-axis to create a distance between theblades, or other cutting member being used, sufficient to create aresultant beam of a desired thickness, then the cutting assemblies arebrought down along the Z-axis and across the stock material 202. Hence,the machine is able to produce straight cut resultant beams, likeresultant beam 520. A straight cut resultant beam 520 will enablegreater and more consistent flexibility, due to the linear shape of theresultant beam, while retaining at least the same torquability as theradius cut beam, without the increased possibility of breakage.

To adjust the relative gap distance (or the resultant beam) between theblades or cutting members, a cut can be made, the resultant beammeasured, and the cutting assemblies can be further adjusted along theY-axis until a resultant beam of the desired width has been created.Alternatively, a reference stock of a known width can be placed betweenthe blades/cutting members until both blades/members touch the referencestock.

As noted, a radius cut beam 510 or a convex cut beam 530 could becreated by the herein disclosed micro-cutting machine by moving thecutting assemblies inward and outward along the Y-axis as each cut isbeing made. It would also be possible to make a variety of other typesof cuts and resultant beams by varying combinations of elements at thesame time, such as rotating the stock material 202 with the rotationmotor as a cut is being made, or rotating the stock material 202 andmoving the cutting assemblies along the Y-axis at the same time. Forexample, a spiral cut could be made by leaving the cutting assemblies ata set Y-axis position while the stock material 202 is rotated by therotational motor. Angular cuts could also be made by mounting the dualblades 214 on a pivot point of some type, or by moving the stockmaterial 202 at a desired angled relative to the Y-axis. In addition tocutting the stock material 202 in the manners already described, only atthe specified angle, other types of cuts could be possible, such asV-shaped notch cuts and the like. As these types of cuts have not beenpossible before, the advantages of the different cuts are not yet fullyknown, but it can already be anticipated that a convex cut beam 530would have even better flexibility and torquability properties thaneither the straight cut beam 520 or the radius cut beam 510.

As previously noted, the automated feedback and control process carriedout by the imaging system 400 and the processor 130 can account forslight variances in cutting blade variations or in variations orimperfections of the stock material itself. The resultant beam, asdiscussed above, is the critical dimension and could be affected by evena single blade variation (such as a single blade tooth being too long)or by a variation of the diameter of the stock material throughout itslength. All these factors are of course integrated into and manifestthemselves in the resultant beam dimension. The precise measurement andadjustment capabilities of the embodiment result in unprecedentedprecision. Upon measurement of the resultant beam, the centering of theresultant beam with respect to the located stock surfaces, and thealignment of the two cuts to each other, the processor 130 can makeadjustments to bring all parameters into alignment to create preciseresultant beam widths. This process can be executed at the beginning ofmanufacture, as a set-up process, as one or more cuts are being made, asa periodic check, or as each and every cut is being made. The softwarerun on processor 130 can be used to validate the repeatability of themicro-cutting machine, possibly reducing the number of measurementsnecessary while cutting a piece, or rendering continuous measurementsunnecessary.

The micro-cutting machine of the embodiment, as previously noted, iscapable of micro-cutting a wide variety of stock materials. Traditionalsingle-blade micro-cutting machines make use of electromagnetic sensingof the precise location of the stock material relative to the singleblade, thereby requiring the use of stock material that is conductive.This condition rules out the use of plastic tubing stock material or anyother non-conductive or minimally conductive material (referred toherein as “non-conductive” even if the material has some relatively lowconductivity that is insufficient to be cut by prior machines).

As discussed, the high definition images and measuring capabilities ofthe imaging system and the precise positioning of the cutting assembliesof the embodiment are much more accurate than relying upon sensing asurface of the stock material because the stock material itself can havean imperfect or inconsistent diameter. Therefore, the herein disclosedmicro-cutting machine is much more accurate and can therefore cut finerdimension resultant beams with greater reliability. The physicalarrangement of the components of the cutting assembly 140 and the stockmaterial 202 make it possible to cut harder materials with less naturalflexibility, like stainless steel, because the resultant beams can becut very narrow while retaining precision. The dual blade micro-cuttingmachine of the embodiment is therefore fully capable of cuttingstainless steel catheters and guidewires (greatly desired by surgeonsfor its ability to hold a shape—allowing the surgeon to personally shapethe tip of a stainless steel guidewire to match the patient'sendovascular system just prior to use), plastic catheters and guidewires(desirable for their great flexibility at relatively wider diameters),and other nonmagnetic stock materials for all types of products.

Flexible yet torquable products are formed by repeating micro-cutsthroughout either the entire length of a piece of stock material, oralong one or more portions of the piece of stock material. Ideally, thepairs of cuts (a pair of cuts refers to one pass by the dual blades eventhough the cuts may not be opposite) are ideally made in a rotatingpattern along the longitudinal axis of the cylindrical stock material. Arotating pattern is preferred because making all cuts at the same anglecreates a product that is biased toward flexing in onedirection—perpendicular to the resultant beam. If the stock material isrotated about its longitudinal axis between a prior cut and a next cutor a prior pair of cuts and a next pair of cuts, then the resultantbeams are not all aligned in the same plane and the flexing bias islessened or eliminated. This rotation between cuts is facilitated byfeed motor 210 and the rotational motor, illustrated in FIG. 2. Feedmotor 210 grips the stock material 202 as the rotational motor rotatesthe stock material 202 along the X-axis (the longitudinal axis of thestock material 202), according to directions received by electroniccontrollers 110 and determined by processor 130. The rotation betweenpairs of cuts is referred to as a variance, and is measured in thedegree of rotation about the longitudinal axis of the stock material.

FIGS. 7A and 7B illustrate two examples of a rotating pattern of pairsof cuts and resultant beams. FIG. 7A illustrates a ninety degreevariance guidewire 601 that was micro-cut using the dual blademicro-cutting machine of the embodiment. Cross-sectional view 620illustrates the two different angles at which pairs of cuts are madewhen the stock material is rotated ninety degrees between cuts. Planeview 630 illustrates how such a guidewire 601 appears along its length.FIG. 7B illustrates a forty-five degree variance guidewire 602 that wasmicro-cut using the dual blade micro-cutting machine of the embodiment.Cross-sectional view 640 illustrates the four angles at which pairs ofcuts are made when the stock material is rotated forty-five degreesbetween cuts. Plane view 650 illustrates how such a guidewire 602appears along its length.

FIGS. 7C and 7D illustrate two more examples of rotating patterns ofcuts and resultant beams that can be produced with the dual blademicro-cutting machine of the embodiment. FIG. 7C illustrates a linearoffset cut configuration 650 where a set of four beams are generatedfrom offset cuts made in the stock material to produce the desiredconfiguration 660. In FIG. 7D, a tribeam configuration 670 is generatedby making a set of three angular cuts, resulting in triangularly shapedresultant beams.

A ninety degree variance, as illustrated by guidewire 601 in FIG. 7A, issignificantly better than aligning all resultant beams in the sameplane, but is still not ideal. The ninety degree variance results inresultant beams that are perfectly perpendicular to each other, whichmay cause the overall guidewire to be biased toward flexing in twodirections—upward and downward, and to the left and to the right, if theguidewire is aligned like guidewire 601 in FIG. 7A. Using a forty-fivedegree variance between cuts, like guidewire 602 in FIG. 7B, can improvethe flexing situation, because the resultant beams are now no longeroppositely aligned in only two planes. This form of cuts evens out theguidewire's flexing properties so that it is not biased in two distinctdirections. In fact, an exemplary embodiment may utilize an unevenvariance between cuts, such as ninety-five degrees, or forty degrees, sothat the pairs of cuts, and therefore the resultant beams, truly spiralaround the longitudinal axis—completely eliminating flexing bias in anyone direction. Of course, the variance used in cutting a product can beeven more complex. For example, advantageous results can be achieved byusing a ninety degree variance between a first cut and a second cut, andthen rotating the stock material slightly, such as by five degrees,before making a third cut and a fourth cut, the third cut and the fourthcut again using a ninety degree variance.

An additional feature of the dual blade micro-cutting machine of theembodiment is an ability to cut a serial number using the blades 214 orcutting member as controlled by the cutting assembly 140, electroniccontrollers 110 and CPU 130 into the stock material 202, so that thefinal product can be individually identified. The serial number or otherform of identification could be formed by creating a series of cuts inthe stock material 202 (possibly circumferentially so they can be readregardless of the rotation of the stock material 202) of varying widthand/or varying spacing that could be read in a manner similar to a barcode.

Finally, it should be noted that while throughout the specification themicro-cutting machine has been described as utilizing a pair of cuttingblades cutting simultaneously, it also may be possible to configure amicro-cutting machine utilizing two or more pairs of cutting blades ormembers operating concurrently. In this way, it may be possible tooperate a plurality of resultant beams all at one time. In such aconfiguration, the pairs of cutting members would all be communicativelyconnected to electronic controllers 110 and processor 130, so that theycan each be adjusted in unison to machine a product meeting the desiredresultant beam parameters.

An alternative technique for forming the micro-cuts along a polymerproduct (or along a portion of the polymer product) involvesthermo-forming all the cuts at once. The process works similarly to apolymer mold, and may begin with industrial polymer pellets in place ofthe previously extruded stock material. Industrial polymer pellets canbe poured into a mold shaped with the desired product structureincluding the desired resultant beam widths, the desired pattern ofbeams along the x-axis, and the desired lumen in the case of a catheter.The mold and the polymer pellets set in the mold are then heated abovethe melting temperature of the particular polymer pellets, flowing themelted polymer into place within the product structure mold. The polymeris then cooled, or allowed to cool, and the now formed product isremoved. Thus, a micro-cut guidewire or catheter can be formed withouthaving to micro-machine individual cuts along the entire length of thestock material.

Several exemplary embodiments of precision products, which can bemicro-machined on the above described micro-cutting machine, will now bedescribed. In general, a guidewire is formed by micro-cutting a solidcylindrical stock material, and a catheter is formed by micro-cutting atubular cylindrical stock material, but in the context of embodimentsdiscussed herein, many other configurations outside of what are commonlyknown in the art are possible. In the prior art, conductive metal stockmaterial was used for both types of products. As discussed above,different materials with superior performance properties, which couldnot be used in the past, can now be feasibly micro-cut into cathetersand guidewires. For example, a guidewire could be formed of stockmaterial other than solid metal stock, such as a tubular stock that hasa wire inserted inside, or a laminar wire formed by coextruding a metalwire and another material around the wire.

Also in the prior art, the micromachined material itself has been reliedupon to provide most, if not all, of the physical body of the productand to almost exclusively dictate the product's performancecharacteristics. Further, in the case of catheters, a sealing tubedisposed on either the outside or the inside of the tube was necessaryto provide a fluid seal (i.e. so that the catheter would indeed functionas a catheter and transmit fluid without leaking from its sides). Thisis not the case in accordance with embodiments where the microfabricatedstock material (whether a tube or solid “wire”—called a monofilament,typically with respect to plastic wires) is merely an interspersedskeleton within a matrix of flexible material that is disposed withinthe machined gaps of the catheter or guidewire. The combination of theinterspersed skeleton and the matrix (or base catheter material) andthat provides an engineered hybrid body (catheter or guidewire) thatdictates most of the structural integrity of the product (withoutreducing flexibility) and drives the product's performancecharacteristics. In the prior art, care is taken to ensure that the gapscut into the stock material are free of any other material, while inembodiments the gaps are completely filled. In the prior art, themachined material may be coated with a very thin polymer layer, such asPARYLENE™, a trademark of Specialty Coating Systems, Inc., but this typeof layer is chosen because it is conformal, rather than a filling layer,and because it is extremely thin, which are all characteristics aimed atminimizing the effects of that coating on the cut stock material. Whilethe micro-cutting machine described herein is capable of making productsfrom “stand alone” cut stock, which are described herein, additionalcapabilities are enabled by using nonconductive materials interspersedwithin the gaps cut into the “backbone” material to form a plasticmatrix that provides a smooth continuous surface, which may be lessthrombogenic due to less surface area. Thus the microfabricated skeletonis merely an interior feature of the product.

Many new products are made possible through use of the presentlydisclosed micro-cutting machine, many of which have not been possible tomake with existing technology. Some, but not all of those products, aredescribed herein and many more that are made possible with the presenttechnology will become apparent to those of skill in the art. One suchproduct is a hybrid guidewire that is formed from polymer stock materialwith a metal wire core running throughout. As the polymer outer layer isnon-conductive, such a product could not be manufactured with existingtechnology, which required a metallic stock material to sense theappropriate place to make each cut. In such a product, using the hereindisclosed technology, a number of options are available. One optioninvolves only cutting through the polymer exterior can with themicro-cutting machine, leaving an uncut metal core, or cutting throughboth the polymer exterior and the wire core. In the former case, a verythin wire core would need to be used in order for the guidewire toretain sufficient flexibility. The polymer stock material should be of ahigh modulus, meaning that the polymer material is rated to berelatively stiff. The polymer PEEK works well for this guidewireapplication, having a modulus of approximately 3700 megapascals. Othertypes of polymers could also be used having a modulus of approximately1.4, such as, PEBA to approximately 138 GPA, such as, PEEK incombination with carbon fibers. Other combinations of materials couldalso be used, such as PEEK made with carbon or glass fibers, which wouldmake the hybrid material stiffer and have a higher modulus.

Including a metal wire running through the centerline of the guidewireprovides additional functionality, in that having such a metal wireprovides a safety wire running down the middle, and facilitates shapingof the guidewire if the metal used is capable of holding a bend.Stainless steel, for example, is capable of holding a bend introduced bya user or surgeon in real-time when extruded at relatively thindiameters, and so may be an appropriate metal to use as the centerwire.The ability to hold the surgeon's precise bend is important becausesurgeon's often like to bend the tip of the distal end of a guidewireduring surgery to precisely address unique circumstances associated witha particular patient. As noted above, in one embodiment, only thepolymer exterior and not the wire metal core is micro-cut, which meansthat even if the micro-cut polymer outer portion breaks while deepinside a patient's vasculature, the centerline metal core should remainintact—allowing the surgeon to retrieve the entire guidewire despite thefact that the polymer portion has been damaged. The polymer outerportion and the solid metal wire core making up the stock material canbe co-extruded at manufacture, before micro-cutting.

Alternatively, a tubular polymer stock material (formed with an emptylumen) can be micro-cut, and then the wire metal core can be insertedinto the lumen. When the core wire is inserted into the tube in thismanner, the diameter of the interior of the tube (the lumen) and thediameter of the exterior of the wire must be chosen carefully, with theentire assembly chosen to match a particular situation. For example, ifthe core wire is too large in diameter, the resulting product will betoo stiff. Generally, a stainless steel core wire having a diameter ofabout 0.002 inches is appropriate to produce a floppy product. Addinganother 0.002 inches or so to the wire creates a net flexibility equalto the superposition of the two. Hence, if the core wire is too muchlarger than about 0.004 inches, the tip of the product will likely betoo stiff.

A second issue is shape-ability. If the wire is too small compared tothe lumen, bending forces applied by the physician will not transmit tothe wire (the wire will simply move within the annular space of thelumen). To account for this, a micro coil is typically inserted into theannular space to transmit the force to the 0.002 inch wire. The coil istypically made of platinum and includes radiopacity at the tip. The corewire can also be bonded to the lumen at the tip only, at the tip andproximal end, or at any of a number of other locations.

To accomplish micro-cutting only the outer polymer portion, theresultant beam should be machined at widths greater than the diameter ofthe centerline wire. In this manner, the centerline wire runs down themiddle of the guidewire through and is essentially encased by theseveral resultant beams. In an embodiment, the polymer guidewire (with ametal wire core) has an outer diameter of approximately 0.014 inches,and the metal wire centerline has an outer diameter of approximately0.002 inches. In an embodiment, the PEEK outer portion is micro-cut tocreate resultant beams of approximately 0.002 inches to 0.012 incheswidth, with the resultant beams cut with an angular variance ofapproximately 75 to 85 degrees.

Alternatively, if the polymer portion and the metal wire centerline arenot co-extruded during production of the stock material, then the PEEKouter portion can be extruded to form an approximate 0.004 inch interiorlumen—leaving enough space for a 0.002 inch outer diameter stainlesssteel wire to be inserted and bonded to the PEEK. The manner in whichPEEK can be bonded to metal is known in the art. In an embodiment, alarger diameter centerline wire can be used and ground down toapproximately 0.002 inches in diameter at one end before being insertedinto the PEEK tube. In an embodiment, a tapered centerline or core wirecould be ground down to a taper at one end so as to further modify theflex profile.

Additional features can be added to the polymer guidewire with a solidmetal core centerline. The fact that the outer portion is polymer allowsa hydrophilic coating to be covalently bonded to the outer surface. Ahydrophilic coating increases the slipperiness of the guidewire, andthereby increases the guidewire's performance by easing travel throughthe patient's vasculature. The present embodiment improves the abilityto hydrophilically coat the guidewire compared to prior art metal(usually nitinol) guidewires, because no tie layer is necessary betweenthe metal surface and the coating. Of course, any coating not requiringa covalent bond could also be applied to the polymer surface. Suchcoatings may benefit from the polymer surface. As previously noted,another embodiment includes placing radiopaque markers on or in thecenterline wire, thus allowing the guidewire to be tracked by X-raydevices while a surgical procedure is ongoing. Additional variations arealso contemplated by the inventors, such as micro-cutting the polymerexterior around the metal core centerline in a spiral pattern so as toto further distribute the flexibility of the device and to avoid biasedflexing.

Another embodiment includes filling the cut gaps or fenestrations thatform the resultant beams at or near the tip of metal core centerlinewith a polymer material to make a manufactured shaped tip that will holdthe shape better. If the wire is made of stainless steel, which holds ashape well, the shape could be formed by the physician at or during thetime of use. If the wire is made of materials that do not hold a shapeas well, the wire can be placed in a mold of the desire shape before thegap filling material is applied. As the filling material cures, themolded shape will hold due to the cured filling material filling thegaps at the desired curves, i.e., less on the inside of the curve andmore on the outside of the curve. This forms a very stable tip shape.The technique can also be used with shapeable metals so that the producthas a pre-shaped tip and can also be further “fine tuned” by thephysician during use.

Another product that can be formed using the above-describedmicro-cutting machine is a guidewire of approximately 175 to 195centimeters in length and approximately 0.0014 inch outer diameter toapproximately 0.0017 to 0.0018 inch outer diameter. As previouslyexplained, the nature of prior art cutting systems have dictated thatsolid metal guidewires be cut from nickel titanium (NiTi or nitinol)versus other metals. The guidewire of the present embodiment can beformed from a solid, continuous piece of nitinol, stainless steel,platinum, or other metal that has been simultaneous cut on opposingsides at numerous positions along some length of the guidewire with themicro-cutting machine described above.

For example, a guidewire micro-cut from solid stainless steel stockmaterial results in a highly torquable and relatively durable (becausesolid stainless steel guidewires will fracture much less easily thancomparable guidewires made from other materials. Forming a guidewirefrom solid stainless steel stock material requires that the resultantbeams be cut accurately to widths smaller than approximately 0.004inches. These solid stainless steel guidewires may also be micro-cututilizing the variances described above, and may also be coated withhydrophilic material, as is known in the art—although an intermediatestep of coating the metal surfaces with a tie layer is required, asdescribed above in the case of covalently bound coatings. Other stockmaterials besides stainless steel may of course be used as well toproduce a solid metal guidewire.

Hybridized guidewires utilizing more than one type of stock material atdifferent points along the length of the guidewire may also be formed.For example, one type of stock material can be micro-cut and used on thedistal portion 15, while a second, different, stock material can beseparately micro-cut and used for the proximal portion 14, with a bondholding the two portions together. For example, a guidewire may beformed with solid nitinol wire for the distal portion 15 and withstainless steel hypotube for the proximal portion 14. The nitinol wirecan be pushed through the stainless steel hypotube so the distal portionextends beyond the end of the stainless steel hypotube forming theproximal portion 14. An embodiment for this example would limit thenickel titanium distal portion 15 to approximately 35 centimeters of theoverall guidewire length (usually 175 to 195 centimeters overall asnoted above), with the remaining length devoted to the proximalstainless steel hypotube. In this embodiment, both portions can bemicro-cut to form resultant beams, or alternatively it may not benecessary to micro-cut the proximal hypotube portion. These hybridguidewires may also be micro-cut utilizing the variances describedabove, and may also be coated with hydrophilic material using the knownintermediate step of coating the metal surfaces when a tie layer isrequired, as described above. Other stock materials besides stainlesssteel and nickel titanium may of course be used as well to produce ahybrid guidewire.

The use of a stainless steel hypotube for the entire length of thecatheter or some proximal portion provides a number of advantages, suchas providing superior proximal support and pushability, which translatesinto more predictable distal vascular access. The greater stiffnessassociated with the stainless steel hypotube also offers the additionaladvantage of straight positioning within the guiding catheter in whichit is inserted, which provides increased operator control of the distaltip. In other words, the stainless steel hypotube is stiff enough not tobend and snake up against the interior walls of the guiding catheter andflop around within the catheter as it is moved by the operator. Higherinjection rates are also possible with the stainless steel hypotube dueto its ability to withstand higher pressure within the guiding catheteras fluid is injected between the exterior walls of the hypotube and theinterior walls of the guiding catheter. Finally, the smooth surface ofthe interior walls of the stainless steel hypotube also presents lessfriction and opportunity for a detachable coil, such as an embolic coil,to catch during insertion delivery.

Polymer catheters may also be formed by micro-cutting polymer stockmaterial on the above described micro-cutting machine. FIGS. 8A and 8Billustrate a cross-sectional view of catheter stock material beforebeing micro-cut (FIG. 8A) and after being micro-cut (FIG. 8B) usingprior art cutting machines. The catheter 801 is formed from a hollowstock material that forms the interior area or lumen 810 which isdefined or formed by the lumen wall 811 of the exterior stock material812. When used in an intravascular procedure, a guidewire 870 can beplaced through lumen 810, where guidewire 870 is usually ofsignificantly smaller diameter than the diameter of lumen wall 811. Thelumen gap 820, defined by the difference between the outer diameter ofguidewire 870 and the inner diameter of lumen wall 811, allows a liquid,such as radiopaque dye for example, to be forced through catheter 810while guidewire 870 is also in place.

There are a number of problems with cut catheter products using priorart micro-cutting machines as is illustrated in FIG. 8B. One significantissue is that the prior art machines are only capable of cutting theresultant beams with a concave cut because each blade is moved at anangle perpendicular to the length of the stock material and the blade iscurved, so it cuts in an arc with more material in the middle of thecatheter being cut than on the outer edges of the catheter. FIG. 8Bexaggerates the significance of this difference (between the inner beamand the outer beam) to illustrate this point. If the blade has asignificantly larger diameter than the diameter of the stock material,the difference will not be as big, but may still be of greatsignificance because it weakens the lumen walls at exactly the wrongpoint, as further explained below. To avoid this problem, it isnecessary for prior art machines to use blades having significantlygreater diameters than the stock material so as to negate thisdifference as much as possible. Otherwise, the “hourglass” shape of theresult beam places the larger width at the top and bottom—exactly whereit is not wanted from a flexibility perspective—and places the thinnestwidth in the middle—also exactly where it is least desire.

When the micro-cuts in the exterior stock material 812 used to formresultant beam 520 penetrate too far into the exterior stock material812, they can potentially pierce through the lumen wall 811. When thisoccurs, the catheter 810's lumen 810 can no longer retain all of theliquid being forced through it. Furthermore, even if the micro-cuts usedto form the beam 520 did not penetrate the lumen wall 811, the resultantlumen wall 811 may be too thin to withstand the pressure formed by theliquid forced through catheter 810, thereby causing the lumen to breakand liquid to leak out through resulting gaps or fenestrations.Regardless of the manner in which a leak occurs, leaks are almost alwaysunacceptable. Unlike the prior art, with the micro-cutting machinedescribed herein, each cut is made from top to bottom, or vice versa(perpendicular to the width, not the length), so the cuts are straightor convex, but not concave unless a concave cut is actually desired.Thus, the resultant beam is more uniform, more flexible because the beamwidth can be narrower at the outer edges, and less inclined to leakagebecause thicker walls, if desired, can be generated around the lumen.

In an embodiment of a polymer catheter, polymer lumen forming stockmaterial, such as PEEK, may be micro-cut to provide even greaterflexibility, with the micro-cuts purposely breaking through the lumenwall into lumen. To re-establish the fluid integrity of lumen, a polymermatrix can be formed around the cut outer portion of the catheter,filling the gaps or fenestrations in the lumen walls without filling thelumen itself. As further discussed below, this can be accomplished in anumber of ways. Either before or after the matrix if formed, a thinliner tube having an outer diameter that is slightly smaller than theinner diameter of the lumen wall can be inserted through the catheter.The liner is used to smooth the lumen wall, decrease friction, addlubricity, help keep the polymer material forming the matrix fromentering the lumen, and increase the burst pressure strength of theproduct, but the liner would not act as a fluid seal, which function isperformed by the polymer matrix. This type of catheter, with a linertube running throughout some length of the catheter formed of a cutskeletal body with a polymer matrix, is referred to herein as atwo-piece polymer catheter.

In an embodiment of a two-piece polymer catheter, the outside diameterof the overall catheter is approximately 0.039 inches or less toapproximately 0.091 inches or more. This is a relatively simpletwo-piece polymer catheter to produce because the micro-cuts may beformed without worrying about avoiding puncturing through lumen andforming fenestrations. In fact, cutting through the lumen walls can nowbe desirable because it further enhances flexibility. The liner tube ispreferably formed of a highly flexible polymer material, as is known inthe art, because the liner tube needs to be naturally flexible withoutmicro-machining (micro-machining both the outer lumen-forming materialand the liner tube would be cost prohibitive), and does not need totransmit torque (torque is transmitted through the length of thecatheter by the micro-machined, skeletal, outer lumen forming material).Alternatively, the liner tube can be formed of other materials, such aspolytetrafluoroethylene or PTFE, for example. The utilization of a linertube, however, does generally reduce flexibility of the catheter whencompared to other catheters that do not utilize a liner.

It is of course possible to effectively utilize a polymer catheter cutwith fenestrations as described above even without the polymer matrixand without inserting a liner tube. Without the liner tube, a polymercatheter micro-cut to have fenestrations, but cut with the micro-cuttingmachine described above, will have extreme flexibility while retainingsignificant torqueability along its entire length. The catheter's lumenwill not have fluid pressure integrity—a fluid forced through the lumenwill leak out through the fenestrations caused by micro-cutting throughthe lumen wall—but other non-fluid materials may still be forced throughthe catheter and thereby forced deep into the patients' vasculature. Forexample, platinum embolic coils, commonly used to fill aneurysms inpatients, may be effectively pushed through the polymer catheter withfenestrations without issue. This polymer catheter with fenestrationsmay provide the highest flexibility for a given catheter diameterbecause there is no stiffening due to liner tube stiffness, andtherefore may be appropriate for highly curvaceous vasculature or usedas a flow directed catheter when designed appropriately.

Alternatively, a polymer catheter can be micro-machined in a differentmanner than that described above so that the micro-cuts forming theresultant beams do not puncture lumen and cause fenestrations. Toproduce this type of polymer catheter, at least four micro-cuts (twocuts or “passes” with the double blade system) are made in the exteriorstock material, compared to the pair of simultaneous micro-cutsdescribed above. FIG. 9 illustrates a polymer micro-cut catheter withoutfenestrations 901 and no liner tube. Micro-cuts 910 and 912 are made atfour angles, each of which stop short of lumen wall 811, resulting information of a diamond-shaped resultant beam 920. The four cuts can bemade in pairs (910 representing a first pair of cuts and 912representing a second pair of cuts) so that the efficiencies of the dualcutting members described above can be used to full advantage. The dualcutting members can cut the exterior stock material 812 from opposingsides and cut inward, stopping somewhat short of reaching lumen 810.Then, before moving the stock material along the X-axis as is describedabove, the stock material is instead rotated ninety degrees (or someother angle) so the dual cutting member can cut another complementarypair of micro-cuts 912 that stop equally short of lumen wall 811.

As is apparent in FIG. 9, resultant beam 920 is an approximate diamondshape—differing from the approximately rectangular shaped resultant beam520 illustrated in FIG. 6B. How close the pairs of cuts 910 and 912 cancome to puncturing lumen wall 811 depends upon the application for whichthe micro-cut catheter without fenestrations 901 will be used. If lumen810 will be used to carry large quantities of radiopaque dye atrelatively high pressures, for example, then it will be appropriate tostop well short of lumen wall 811 with cut pairs 910 and 912, therebyleaving a relatively thick diamond-shaped resultant beam 920 that canwithstand high pressure liquid flow. If, on the other hand, lumen 810will be utilized solely to carry non-fluid materials like platinumembolic coils, then resultant beam 920 can be machined much thinner bymaking deeper pairs of cuts 910 and 912.

The sharper edges of the diamond-shaped resultant beam 920 apparent inFIG. 9 can be reduced by making additional pairs of cuts, such as cutpair 915, before moving the stock material along the X-axis to the nextdesired resultant beam location. Alternatively, the sharp edges can befurther smoothed by rotating the angle of the stock material during thecutting of a pair of micro-cuts. This step is much like the operation ofa lathe, wherein the stock material is spun (via changing the angle ofthe stock material) while a tool is held in a relatively fixedposition—the tool being the dual cutting members. In another embodiment,the micro-cutting machine described herein can be fitted with one ormore boule saw blades (circular or round saw blades with teeth on theinside diameter), which when utilized to make the pairs of cuts willproduce a much more rounded resultant beam 920. Of course thecombination of the these techniques can be used to form a variety ofwall thicknesses and shapes as desired such as more material at the topand bottom of the diamond (i.e., no diamond point at all, but a widerbeam), and the left and right side might have a rounded cut (fromrotating the stock) providing a relatively uniform wall thickness over aportion of the two sides.

A hybrid catheter, comprising different stock materials for proximalportion 14 and distal portion 15, can also be produced. In thisembodiment, the catheter uses a high strength material as stock materialfor proximal portion 14, such as a braided plastic polymer or astainless steel hypotube. Distal portion 15 is then formed from a moreflexible (lower modulus) material, such as a polymer (PEEK or some othermaterial)), or some other material selected for its desired properties.A polymer or PTFE (or equivalent) liner tube can then be inserted,running up to the entire length of the hybrid catheter and ensuring asmooth lumen surface throughout, while also facilitating bindingproximal portion 14 to distal portion 15. Other forms of binding mayalso be required or desired. In this hybrid catheter, the relativelengths of the stiffer proximal portion 14 and the more flexible distalportion 15 can be optimized for the particular application, or even forthe individual patient, if desired. Distal portion 15 can encompass moreof the entire catheter length, if the procedure requires deeppenetration of the complex vasculature of the brain, for example. Inthis case, the stiffer proximal portion 14 would consequently encompassless of the overall catheter length. Similarly, if a particularpatient's vasculature differs greatly from the norm for a particularprocedure, then the relative lengths of stiff proximal portion 14 andflexible distal portion 15 can be individually tailored to suit thatindividual's vasculature. Depending upon the stiffness of the proximalmaterial, it may be advantageous (and perhaps safer) to reduce thelength of the proximal portion 14 such that it cannot reach certainanatomy (such as the carotid siphon) or so that it remains within thelength of another medical devices such as a guiding catheter.

Alternative embodiments include products having proximal portions 14formed of stainless steel or other more rigid materials and distalportions 15 formed of highly flexible materials, such as PEEK ornitinol, with the proximal portion 14 joined to the distal portion by anintermediate joint, where the proximal portion 14 is firmly secured tothe distal portion 15. Hybrid products of this type enable a highlyflexible, steerable and torqueable distal portion 14 (such as a PEEKskeleton coated with a PEBA matrix, as described above and below) to becombined with a thick and strong proximal portion 14 that can be easilyheld and handled by a surgeon.

An embodiment comprising micro-cut catheters and guidewires includingone or more layers of elastomeric material (any polymer or plasticmaterial with especially elastic properties) refilling micro-cuts willnow be further described. This refilling, reflowing or laminatingtechnique can be applied to any of the above described catheters orguidewires with advantageous results. Additionally, this technique canbe applied to prior art micro-cut catheters and/or guidewires to improvetheir performance.

FIG. 10A is an illustration of a micro-cut catheter or guidewire thatshows a temporary deformation that may occur when a catheter orguidewire is bent, or subjected to torque, during the normal course ofuse of the device. This deformation may occur in guidewires andcatheters micro-cut using prior art techniques as well as guidewires andcatheters cut using the micro-cutting machine herein disclosed. Theelastomeric laminate technique described above and further belowalleviates this deformation in both guidewires and catheters, regardlessof the manner in which they have been micro-cut. For purposes ofconvenience and simplicity, the elastomeric laminate technique of thepresent embodiment will be described below with regard to a micro-cutguidewire, but it should be understood that the same discussion appliesequally to micro-cut catheters, as described above.

In FIG. 10A, a simplified view of a segment of a non-laminated guidewire1001, micro-cut to form resultant beam 520 and rings 1010. When anon-laminated guidewire 1001 is highly flexed, as will occur when theguidewire is deeply inserted into a patient's vasculature, rings 1010may be stressed and may bow as a result. This bowing is represented inFIG. 10A by the dotted line 1015. Bowed ring 1015 is stressed and in adeformed position, which causes the entire non-laminated guidewire 1001to transmit a surgeon's torque inefficiently and erratically from torque12 to distal tip 13. This is problematic because the surgeon would liketo have complete control over distal tip 13. Torque may be transmittedmore effectively from torque 12 to distal tip 13 if rings 1010 can bekept in alignment while the guidewire is flexed throughout the patient'svasculature.

The reinforced matrix 1060 illustrated as the blackened area in FIG. 10Bprovides a solution to the bowed ring 1015 problem without compromisingthe flexibility of the product, but the reinforced matrix also servesmany other useful purposes, in addition to solving the bowed ringsproblem. For example, the reinforced matrix 1060 provides cushioning tothe rings 1010, help to limit total movement within desired ranges, andbalances forces within the product by transmitting forces applied to onering to the next ring, operating much like vertebrae disks in thebackbone of humans and other vertebrates. As shown in FIG. 10B, themicro-cuts formed between the rings 1010 are refilled or reflowed withan elastomeric material that fills the gaps and coats the exterior ofthe guidewire 1001, as illustrated by the darkened area 1060. Inessence, the micro-cut guidewire forms an internal, relatively rigid,but flexible and torqueable, skeleton for the product, while theelastomeric laminate provides a highly flexible integrated skin ormatrix around the skeleton. When elastomeric laminate 1060 is used tofill the spaces created by the skeleton, the rings 1010 of the laminatedguidewire 1001 are kept in alignment (or at least closer to alignment)due to the resistance created by the laminate to any pressure exertedagainst the rings 1010, even when the guidewire is flexed, or bent,throughout the patient's complex and curvaceous vasculature. Byrefilling the micro-cuts with an elastomeric material, the rings 1010are forced to “bounce back” from any bowing which may occur when theguidewire is flexed. An added benefit of the elastomeric lamination isthat if a resultant beam or a ring happens to break while inside apatient's vasculature, the guidewire can remain in one piece via thesurrounding laminate material—significantly easing removal.

Elastomeric laminate 1060 is ideally an elastic material having adurometer (a measure of hardness) or modulus (a measure of stiffness)significantly below that of the stock material forming the rings 1010and resultant beams 520 of the guidewire. This is so the laminatefilling material does not have adverse effects on the overall guidewireflexibility. For example, if the guidewire is micro-cut from PEEK stockmaterial, as described above, then a relatively soft and flexibleelastomeric material such as polyether block amide (PEBA) can be used asthe laminate filling. Such a combination is advantageous because PEEKhas a modulus (stiffness) of approximately 3700 MPa, while PEBA has amodulus of approximately 10 to 500 MPa (depending on productionconsiderations). As a result, the flexibility of the micro-cut PEEKskeleton or substructure will hardly be affected by the much more highlyflexible PEBA laminate skin or matrix.

Nevertheless, in the event the addition of the PEBA skin or matrix doesimpede the flexibility of the micro-cut guidewire in some manner, theskeleton or substructure can be made even more flexible, therebycounteracting any impediment created by the skin or matrix, by alteringthe micro-cut pattern to include more micro-cuts along the length of theguidewire or catheter, thereby increasing its overall flexibility.Alternatively, each pair of micro-cuts can be made deeper resulting inthinner resultant beams and thereby alternatively increasingflexibility. While an increased number of micro-cuts or deepermicro-cuts may be undesirable in a non-laminated guidewire, the presenceof the skin or matrix provides the additional safeguard of holding theskeleton or substructure together in the event of a breakage, so moremicro-cuts and/or deeper micro-cuts are made possible with the presenceof the skin or matrix. In this manner, the properties of the individualcomponents can be engineered so that they perform as desired as asystem, providing new and better overall performance.

The PEBA skin or matrix can be applied in a number of manners, such ascoating an uncoated guidewire with the PEBA material in a machine thatapplies the coating and dries or cools the material in place beforeexiting the machine. A PEBA skin or matrix can be placed around acatheter in a similar manner by placing the catheter over an internalmold that fills the hollow central area, while the PEBA coating isapplied and dried/cooled to hold it in place, then removing the internalmold so as to leave the resulting lumen 810. An alternative embodimentfor applying the elastomeric laminate over the guidewire involvespulling a tube formed of the desired laminate material over a length ofthe micro-cut guidewire, heating the laminate-guidewire/cathetercombination to a temperature above the melting point of the laminatematerial but below the melting point of the stock material, and thencooling the coated guidewire to form the skin or matrix.

With regard to a catheter, a liner or Teflon coated mandrel could beinserted into the hollow central area of the catheter while a tube ispulled over the exterior, such that when heat is applied to the tube andliner they melt together forming the skin or matrix and leaving thelumen. For example, PEEK has a melting point of approximately 343degrees centigrade and PEBA has a melting point of approximately 134 to174 degrees centigrade depending on how exactly the PEBA was produced.Therefore, a tube or liner formed of PEBA can be pulled over and/orinserted into either a portion of, or the entire length of the guidewireor catheter micro-cut from PEEK stock material, and then the combinationcan be heated to 175 degrees centigrade to form the skin or matrix. ThePEBA laminate will melt into the micro-cuts between the rings 1010, butthe PEEK rings 1010 and resultant beams 520 will not melt and remainapproximately unaltered.

Alternative materials can also be used for the integrated liner otherthan PEBA, such as PTFE, that will melt and integrate with the outertube melted around the outside of the catheter, which can also be madeof other materials. A mandrel may still be inserted within the interior,integrated liner prior to integration to ensure that the interior lumenwalls are as smooth as possible, so as to prevent an embolic coil fromcatching on any deformation on the interior of the catheter as the coilis pushed along the interior length of the catheter. As a result of thephysical transformation of the outer tube or inner liner as a result ofbeing integrated, the final product does not include either an outertube or an inner liner, but rather a fully integrated skin or matrixaround the skeletal structure of the guidewire or catheter. When amandrel is used to form the lumen, the mandrel is pulled from the tubeafter the matrix has been melted and formed around the skeleton, leavingthe lumen. The mandrel would be coated with a material that does nointegrate with the skeleton and enables the mandrel to be readilyremoved.

Those skilled in the art will recognize that there are myriadpermutations of resultant beam width, x-axis distance between resultantbeams, stock materials, and laminate materials that can be combined toproduce laminated guidewires and catheters of various flexibilities andstrengths. This specification intends to cover all such permutations ofa micro-cut skeletal guidewire/catheter substructure with an integratedflexible matrix, which may also be referred to as a reinforced skeletonor substructure. For example, it is possible to combine a stock materialand a laminate material that are much closer in properties (stiffnessand/or melting temperature, for example). Materials with significantlycloser properties may interact more during the melting phase—with stockmaterial crossing the theoretical boundary between where the ring andresultant beam substructure ends and where the laminate layer begins,and vice versa—resulting in a guidewire/catheter with advantageousflexing and torquing properties. In another example, it is possible toutilize more than one layer of laminate, and each layer may be formed ofa different material with differing properties.

The herein disclosed laminated micro-cut guidewire/catheter can in factbe thought of as essentially a highly flexible catheter with a rigidsubstructure or skeleton to facilitate torque transmission—an entirelynew product vastly different than currently available micro-cutcatheters and guidewires. An additional benefit to the laminatingtechnique is that the laminate material serves to encapsulate some orthe entire micro-cut outer surface of the guidewire or catheter and thussmoothing any burrs, and trapping any debris, that may have formedduring the micro-cutting process. This is an additional protection forthe patient against any foreign material that may otherwise be releasedinto the body.

A further embodiment of the micro-cut skeletal guidewire/cathetersubstructure with an integrated elastomeric matrix involves the creationof a shape holding tip, as also initially described above. The shapeholding tip product is generated by producing a skeleton for a productand placing the product in a mold or shaped mandrel that holds the tipof the product in a particular position, such as with a slightly curveddistal tip. The skeleton is then filled with PEBA to fill in the cuts,but as the cuts are filled, the cuts on the inside of the curved tipwill be filled with less PEBA than the cuts on the outside of the curvedtip, causing the curved tip to hold its shape once the PEBA has set.

Another embodiment includes a stainless steel hypotube proximal portionthat is wrapped around its exterior with a polyethylene shrink tubingthat extends beyond the distal end of the hypotube or even beyond thedistal end of the machined portion (the very tip of the device). Whenthe shrink tubing is heated or re-melted, it will shrink to form a tightseal or bond around the hypotube, but will only shrink so far at thedistal end, leaving a shrink tube catheter at the distal end with asmaller diameter and possibly with a much more flexible tip. Analternative embodiment involves running a micro-cut catheter through aportion of or the entire length of the hypotube and extending beyond thedistal end of the hypotube, around which the shrink tube can form. Thedistal portion of this embodiment would have a smaller outer diameterthan the outer diameter of the hypotube so that the catheter taperstoward the distal end.

These different types of microfabricated distal sections (MDS) have anumber of advantages: they are kink resistant and do not ovalize, whichprevents coils from jamming inside the catheter's distal end; they allowfor increased torque transmission and operator control of the distaltip; they allow for increasing the diameter while maintaining superiorflexibility; they allow for greater tip stability during delivery ofdetachable coils or other embolic materials; and they allow forpaintbrushing without prolapsed of the distal tip. Paintbrushing refersto the side to side motion of the distal tip, which is necessary forcertain operations, such as the more precise placement of detachablecoils into desired locations. The ability to paintbrush may also allowfor more compact and complete occlusion of vascular anomalies, such asintracranial aneurysms. It may also allow for placing one or twoadditional coils than might otherwise be possible with prior art devicesbecause the operator can manipulate the distal tip to place it in anarea of the aneurysm that still requires filing.

An alternative embodiment involves attaching a micro-cut catheter to theend of the hypotube that has a larger outer diameter than the hypotubeand shrinking shrink tubing around both the proximal and distal portionsto help hold the distal portion in place and provide fluid integrity. Ifnot clear from above, the shrink tubing just provides an alternativesubstance and method for forming the flexible matrix for the same orother skeletal based structures already described. In any of theseembodiments, radiopaque markers could be placed near the distal tip ofthe catheter.

Other embodiments involve assembling a skeletal structure catheters froma number of different micro-cut tubes of different durometers andvarying lumen wall thicknesses, and either cutting each of tubesaccording to the same pattern, or varying the pattern for the differenttubes. For example, over some sections of the catheter, the cuts may bemade very close to one another, while in other sections, the cuts may befurther spaced apart. Likewise, in some sections, the resultant beamsmay be bigger than in other sections. Numerous different variations tothe pattern are possible.

A kink resistant proximal portion can be created by micro-cutting asection of PEEK tubing and laminating that section with PEBA, asdescribed above. This combination will allow the proximal portion tobend without kinking. The stiffness of the proximal portion can also bevaried by varying the cut spacing between cuts and the depth of eachcut, as well as by varying the durometer of the elastomeric materialused in the lamination.

A reinforced substructure catheter of the type described herein alsocreates new possibilities for utilization. The thin lumen walls of priorart catheters cannot withstand significant pressure from within thelumen without having the lumen collapse or having the lumen wallsrupture. As a result, the same highly flexible catheters that are oftenused to place embolic coils in curvaceous vasculature, such as in thebrain, have not be usable to remove blood clots that may also be presentwithin the brain because the blood clots need to be extracted byapplying vacuum pressure to the catheter at the proximal end 11. Thereinforced substructure catheter embodiment (even with a skeletalstructure having an outer diameter as small as 0.005 inches), however,is flexible enough to be able to reach far into the vasculature of thebrain, yet strong enough to be able to withstand vacuum pressure appliedat the proximal end 11 that is sufficient to enable the extraction ofblood clots.

As described above, the elastomeric matrix technique can be utilized toforgo the need for a liner tube on the outside or the inside of amicro-cut catheter that has been micro-cut through its lumen walls asdescribed above. FIG. 11 illustrates a method for producing liner-freelaminated catheter 1101. In FIG. 11, the dotted line represents originallumen wall 1120 formed by the stock material. As can be inferred fromthe location and width of resultant beam 520, when the catheter wasmicro-cut, the pairs of cuts penetrated original lumen wall 1120,producing fenestrations throughout the length of the catheter anddestroying the fluid pressure integrity of the lumen. The depth of suchfenestrations may be exaggerated by FIG. 11. But this fluid pressureintegrity can be re-established during lamination by formation of theelastomeric matrix 1060 within the fenestrations throughout the lengthof the catheter. The elastomeric matrix 1060 can be formed in a numberof different manners, including through the use of shrink tubing orother materials that can be placed on the outside and/or inside of theskeletal structure and melted or otherwise integrated together to formthe matrix 1060.

A releasable mandrel coated on its outer surface with TFA, PTFE, oranother non-stick layer, so as to facilitate easy removal following themelting stage, could also be inserted into the lumen 810 to help moldthe matrix 1060 as it is being formed. The releasable mandrel can beinserted into the lumen 810 after micro-machining the stock material andbefore pulling a laminate material tube overtop or otherwise creatingthe outer surface of the matrix 1060. The laminate material is thenheated and melted, or otherwise integrated, such as described above,forming laminate matrix/layer 1060. As is apparent in FIG. 11, laminatelayer 1060 will fill in the micro-cuts, around rings 1010. After themelting stage, the releasable mandrel (is used) can be removed,resulting in a new lumen wall for the lumen 810. Depending on what typeof laminate material is used, it may be necessary to then coat the newlyestablished lumen walls with a hydrophilic coating. For example, if PEBAis used as a laminate material then a hydrophilic coating may berequired inside the lumen because PEBA is relatively non-slippery.

As previously described, a soft tip configuration, which may beimplemented with any of the above-described catheters and guidewires,will now be described. FIG. 12 illustrates the soft tip configuration asimplemented on a hybrid catheter, but it should be noted that the sameprocess can be applied to implement a soft tip configuration on aguidewire. Soft tip hybrid catheter 1251 includes a stainless steeltubing proximal portion 1252, an elastomeric laminated distal section1261 encasing a micro-cut polymer catheter, and a liner tube 1254running at least part of the way between the proximal portion and thedistal portion. The liner tube 1254 would typically be a slipperymaterial that lacks the strength to retain fluid, but helps to improvethe movement of a guidewire or coils through the lumen. The soft tipconfiguration includes two portions of the catheter: a thinner wallsection 1210 and a soft tip section 1220.

The thinner wall section 1210 can be formed in a number of differentmanners, such by increasing the size of the lumen near the distal end,such as by drilling or otherwise removing some portion of the lumenwalls along section 1210. A larger lumen can also be formed by formingthe matrix differently along this section 1210, such that the lumenwalls are thinner and the lumen is larger, such as using a slightlylarger diameter mandrel at the distal end than along other portions ofthe catheter.

Soft tip section 1220 encompasses the most distal portion of soft tiphybrid catheter 1251, and comprises either the liner tubing 1254extending beyond the end of the micro-cut polymer catheter section, oran outer covering extending beyond the end of the section. This soft tipsection 1220 can be wrapped with relatively thin gauge radiopaque wire1240 (having a diameter of approximately 0.002 to approximately 0.003inches), both to provide x-ray visibility while inside the patient'svasculature and to facilitate the taking of a set, or a bend, fixed bythe surgeon prior to a procedure. The radiopaque wire 1240 can be coiledrelatively tightly around soft tip section 1220 in order to slightlystiffen the soft tip configuration and to robustly hold the surgeon'scustom bend, or the radiopaque wire 1240 can be coiled more loosely inorder to soften the soft tip configuration and to more loosely hold thesurgeon's custom bend.

The soft tip configuration is advantageous for several reasons. Theconfiguration smoothly transmits torque from torquer 12 (not shown inFIG. 12), through proximal portion 14 (stainless steel tubing 1252 asillustrated in FIG. 12) and the micro-machined polymer section to themost distal portion of the catheter, soft tip section 1220. Theconfiguration also provides a gradual stiffness transition from themicro-cut section through the reduced outer diameter section to the softtip section. Finally, as described above the radiopaque wrapped soft tipsection 1220 can take and hold a set, allowing the surgeon toindividually optimize the shape of the tip for a particular applicationor procedure.

The soft tip configuration can be utilized to produce a soft tip guidingcatheter that has a larger internal diameter without increasing theexternal diameter of the catheter. Guiding catheters are typically of alarge diameter, having a relatively large diameter lumen, so as tofacilitate pumping large volumes of fluid, such as radiopaque dyes orliquid medications, to particular locations within a patient'svasculature. The typical large diameter, however, makes these guidingcatheters much more rigid than smaller diameter catheters ormicro-catheters. But as explained above, the dual-blade micro-cuttingmachine allows micro-cutting of polymer stock material—allowing largediameter lumen-forming polymer stock material to be micro-machined intomore flexible catheters. This is especially advantageous for travelingthrough a patient's carotid siphon, a portion of the human vasculaturethan is especially curvaceous. Previously, it was impossible to producea large diameter polymer guiding catheter of sufficient flexibility(while retaining torque transmission capabilities) to travel through thecarotid siphon, but the dual-blade micro-cutting machine describedherein is capable of micro-cutting lumen-forming polymer stock materialto the appropriate flexibility. In an embodiment, this guiding catheteris a two piece catheter micro-cut from large diameter polymer stockmaterial with a soft tip configuration as described above at its distalend.

For certain types of surgical procedures, it is desirable to use aflexible guiding catheter to reach a particular point, and to then use asmaller catheter or guidewire inserted inside the larger guidingcatheter to reach further points in the body. For example, a guidingcatheter of the type described above could be used to reach and extendaround the curve of the carotid siphon, and once that has been achieved,to use the smaller catheter or guidewire to reach other vascular in thebrain. Under such circumstances, it is also desirable to be able to pushcontrast solution or other fluids in the lumen gap, which is the gapdefined by the difference between the lumen walls and the outside of theinserted catheter, such as a microcatheter. The walls of the lumen aresaid to define the outer diameter of the lumen gap, while the outerdiameter of the microcatheter is said to define the inner diameter ofthe lumen gap. Hence, if a guiding catheter has an outer diameter of0.056 inches and the microcather and an inner diameter of 0.039, thereis 0.017 inches worth of space left to form the lumer gap, which is oneither side of the microcatheter, so essentially leaving 0.0085 incheson either side of the microcatheter through which to push fluid. Thissmall lumen gap can require a surgeon to exert some significant force inorder to push the fluid all of the way along the length of the guidingcatheter.

It has been known in the prior art to taper the outer diameter of thedistal end of a microcatheter because the flexibility of a catheter (orguidewire) increases by the fourth power of the outer diameter of theproduct, and high flexibility at the distal tip is important in manyapplications. For example, the diameter of a prior art microcatheter maygo from 0.039 inches at the proximal portion, where fluid is beingpushed by, to a diameter of 0.028 inches or 0.030 inches at the distaltip, which has passed beyond the guiding catheter and is now in the openvasculature. The problem with this design is that the microcatheter isactually bigger where it needs to be small and smaller where it coulduse to be a little larger.

A embodiment of the micro-cut catheter described herein solves thisproblem by actually reducing the diameter of the inserted catheter alongthe length of the proximal portion that is within the guiding catheterso that is easier for a surgeon to push fluid through the lumen gap.Using the same example as above, by reducing the diameter of theinserted catheter along the proximal section from about 0.039 to about0.030, the lumen gap is increased by more than about 50%. At the sametime, because of the enhanced flexibility of herein described micro-cutproducts, the diameter of the microcatheter at the distal end can beincreased to about 0.039 inches, giving the surgeon great control andtorqueability where it is needed the most. This is only possible due tothe highly flexible design of the micro-cut material used for the distalportion and/or the distal tip of the catheter, such as PEEK, which hasall of the flexibility of a much small prior art distal tip formed ofother materials.

Generally, the modulus of elasticity of the material used to form theskeletal structure of an integrated matrix product can be less thanapproximately 19 Mpa. As the modulus of the material used increase, thebeam size can decrease, further enhancing flexibility, but introducingthe potential for breakage when the material is stressed beyond abreakage point for the material. The introduction of the integratedmatrix actually servers to provide a more linear deformation range forthe product because it provides support for the skeleton withoutimpeding flexibility. If a higher modulus is desired, the polymer(plastic) material used as stock material for each of the abovedescribed catheters and guidewires can be stiffened (the material'smodulus can be increased) by the addition of fibers prior to extrusion.Glass or carbon fibers can be added to the mix of industrial polymerpellets before the pellets are extruded to form the stock materialdescribed above. The fiber acts in much the same way as rebar inconcrete—including veins of the higher modulus material throughout thepolymer increases the overall modulus of the polymer.

In addition to the advances in products described above, an easier touse and more efficient torqueable hub is also disclosed herein withreference to FIG. 13. Prior art torqueable hubs typically have two largewings or flanges, like certain types of fishing lures that are designedto flutter as water rushes past. The wings or flanges protrude fromopposite sides of the hub and are intended to give a surgeon asubstantial area to hold and push against when seeking to turn thecatheter during an operation. The hub also typically includes an axialspace into which a syringe can be inserted so that fluid can be pushedinto the catheter. The lure shaped hub, however, is oddly shaped and canbe awkward for a surgeon to grip and turn. This shape also impedes thesurgeon's ability to exert fine motor skill controls with their fingers,due to the large size of the winged structure.

FIG. 13 illustrates an improved torqueable hub 1300 that has abarrel-shaped body 1310 that includes a plurality of longitudinalgrooves 1320 formed in and around the exterior of body 1310. Thediameter of the barrel body 1310 is approximately 0.5 inches. The sizeand shape of the barrel body 1310, coupled with the grooves 1320, givethe surgeon a better and more comfortable grip and allow the surgeon toexert much finer control of the torqueable hub 1300, and therefore moreaccurately control of the catheter. The torqueable hub 1300 alsoincludes an axial interior space, illustrated by the dotted lines 1330,into which a syringe can be inserted.

Many useful and novel devices can be fashioned using micro fabricatedelongate members. Such devices are not limited to having just a roundcross-section, as is most often seen, but may include other shapes suchas oval, square, triangular, or arbitrary, that is, non uniform shapes.These members can be of almost any cross sectional dimension, from verysmall, such as approximately 0.004″, to very large, such as, up toseveral inches, indeed there is no size limitation as the presentembodiments can be scaled according to the desired application. Themicro-fabricated detailed structures, referred to herein as “beams” or“resultant beams” and “rings” are fashioned to optimize the performanceof the elongate members for their desired purposes. These structures canbe formed using a micro-fabrication machine, or other by other methodssuch as laser cutting. For larger structures, what is referred to as“micro-fabrication” may not be necessary, rather more conventional andlarger fabrication tools and techniques may be used. In thesestructures, the general objective of optimizing performance such astorque transmission, flexibility, and push (axial strength) can beachieved just the same as with micro-fabricated structures employing abasic scale up of size.

The following are some of the examples of novel and useful elongatemembers that can be made using embodiments disclosed herein. Theseexamples are directed to round structures that are of the general sizefor medical applications, however the embodiments taught herein arereadily applicable to other applications where alternate sizes, andshapes are desired.

Examples of structures fabricated with beams, rings, and the like taughtherein are as follows:

Example 1

A solid mono-filament stock material of metal or polymer, or othermaterial.

Example 2

A solid mono-filament stock material that is a composite, for example,co-extruded with various polymer layers, or glass fiber filled or carbonfiber filled materials.

Example 3

A solid mono-filament material that may be a polymer that has beencoated over a wire such as stainless steel.

Example 4

A tubular member made with any of the materials as above, where theinterior lumen is not breached by the cutting of features ormicro-fabrication.

Example 5

A tubular member as in Example 4 where the lumen is breached by thefeature cutting.

Example 6

Any tubular member such as in Example 5 where there is also a wiredisposed in the lumen.

Example 7

All of the above Examples 1 to 6, where the cut features (gaps orfenestrations) are substantially filled such that the outer surface isrelatively smooth and the adjoining rings of the structures areessentially in mechanical contact with each other through the fillingmatrix material, such as polyether block amide, also referred to as PEBAor Pebax™, which is of lower modulus than the cut material.

Example 8

As in example 7 where the matrix material completely encapsulates thecut material, including interior portions for tubular material formingan interspersed skeleton of stronger material inside a fluid sealed wallof the matrix material.

Example 9

As in example 8 where some of the cuts or fenestrations are left openfor fluid delivery or other purposes.

Example 10

In an example of an elongate member used for catheters or guidewires,the above examples can be fashioned for use by using the member for theentire length, for example, 175 cm of in the case of one type ofcatheter.

Example 11

Devices and structures contemplated herein also includes members havingmultiple lumen, such as, a catheter, guidewire, or the like, having two,three or more lumen.

Example 12

Devices and structures contemplated herein also includes members usingbraiding.

Any of the examples above could be used in segments together, or withother materials to form various catheters or guidewires or any otherstructure to form elongate members of various segments along the length.These segments may have a larger or smaller relative cross section andbe placed at various locations relative to one another such as at adistal segment or proximal segment in the instances of medical devices.These materials may include solid stainless steel or other material,including a stainless steel wire that is ground to a taper, or a tubularstructure of stainless or other material. These adjoining segments mayinclude some micro-fabricated features along all or part of the length.Further, the various segments may use a portion of the adjoiningsegment, such as, a continuous interiorly disposed member of Example 6,where the wire might continue from one segment to another.

An embodiment of the present invention provides a catheter devicecomprising: a micro-fabricated elongated outer member having an outersurface and an interior surface forming a lumen extending from aproximal end to a distal end and a plurality of fenestrations madethrough the outer surface and the interior surface into at least aportion of the lumen; and an outer elastomer laminate layer in contactwith at least a portion of the outer surface and filling the pluralityof fenestrations.

An aspect of the present embodiment further comprising a torqueable hubconnected to the proximal end and having a barrel-shaped body with aplurality of longitudinal grooves formed therein, and further forming anaxial interior space within which a syringe can be inserted.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member has a plurality of resultant beams, eachresultant beam formed between adjacent fenestrations among the pluralityof fenestrations.

An aspect of the present embodiment is where the outer elastomerlaminate layer substantially covers all of the resultant beams.

An aspect of the present embodiment is where the outer elastomerlaminate layer covers completely all of the resultant beams.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member forms an interspersed skeleton and wherein theouter elastomer laminate layer forms a matrix of flexible material thatis disposed around the interspersed skeleton.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member is formed from polyetheretherketone.

An aspect of the present embodiment is where the outer elastomerlaminate layer is formed from polyether block amide.

An aspect of the present embodiment further comprising a lubriciousliner formed from PTFE in contact with the interior surface.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member is formed from a material having a modulus valueof about 3700 MPa.

An aspect of the present invention is where the outer elastomer laminatelayer is formed from a material having a modulus value of about 12 MPa.

An aspect of the present invention is where the outer elastomer laminatelayer extends beyond the distal end to form a hollow distal tip.

An aspect of the present invention is where the hollow distal tipincludes a wire holding a shape for the hollow distal tip.

An aspect of the present invention is where the hollow distal tipincludes a radiopaque marker.

An embodiment of the present invention provides a guidewire devicecomprising: a micro-fabricated elongated outer member having an outersurface and an interior surface forming a lumen extending from aproximal end to a distal end and a plurality of fenestrations madethrough the outer surface and the interior surface into a least aportion of the lumen; an outer elastomer laminate layer in contact withat least a portion of the outer surface and filling at least a portionof the plurality of fenestrations; and an inner member disposed within asubstantial portion of the lumen.

An aspect of the present embodiment is where the inner member is amonofilament wire core.

An aspect of the present embodiment is where the inner member is ahypotube.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member has a plurality of resultant beams, eachresultant beam formed between adjacent fenestrations among the pluralityof fenestrations.

An aspect of the present embodiment is where the outer elastomerlaminate layer substantially covers all of the resultant beams.

An aspect of the present embodiment is where the outer elastomerlaminate layer covers completely all of the resultant beams.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member forms an interspersed skeleton and where theouter elastomer laminate layer forms a matrix of flexible material thatis disposed around the interspersed skeleton.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member is formed from polyetheretherketone.

An aspect of the present embodiment is where the outer elastomerlaminate layer is formed from polyether block amide.

An aspect of the present embodiment, further comprising a lubriciousliner formed from PTFE in contact with the interior surface.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member is formed from a material having a modulus valueof about 3700 MPa.

An aspect of the present embodiment is where the outer elastomerlaminate layer is formed from a material having a modulus value of about12 MPa.

An aspect of the present embodiment is where the outer elastomerlaminate layer extends beyond the distal end to form a hollow distaltip.

An aspect of the present embodiment is where the hollow distal tipincludes a wire holding a shape for the hollow distal tip.

An aspect of the present embodiment is where the hollow distal tipincludes a radiopaque marker.

An embodiment of the present invention provides a catheter devicecomprising: a micro-fabricated elongated outer member having an outersurface and an interior surface forming a lumen extending from aproximal end to a distal end; and an outer elastomer laminate layer incontact with at least a portion of the outer surface.

An aspect of the present embodiment, further comprising a torqueable hubconnected to the proximal end and having a barrel-shaped body with aplurality of longitudinal grooves formed therein, and further forming anaxial interior space within which a syringe can be inserted.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member has a plurality of resultant beams, eachresultant beam formed between adjacent rings among the plurality ofrings.

An aspect of the present embodiment is where the outer elastomerlaminate layer substantially covers all of the resultant beams.

An aspect of the present embodiment is where the outer elastomerlaminate layer covers completely all of the resultant beams.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member forms an interspersed skeleton and wherein theouter elastomer laminate layer forms a matrix of flexible material thatis disposed around the interspersed skeleton.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member is formed from polyetheretherketone.

An aspect of the present embodiment is where the outer elastomerlaminate layer is formed from polyether block amide.

An aspect of the present embodiment, further comprising a lubriciousliner formed from PTFE in contact with the interior surface.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member is formed from a material having a modulus valueof about 3700 MPa.

An aspect of the present embodiment is where the outer elastomerlaminate layer is formed from a material having a modulus value of about12 MPa.

An aspect of the present embodiment is where the outer elastomerlaminate layer extends beyond the distal end to form a hollow distaltip.

An aspect of the present embodiment is where the hollow distal tipincludes a wire holding a shape for the hollow distal tip.

An aspect of the present embodiment is where the hollow distal tipincludes a radiopaque marker.

An embodiment of the present invention provides a guidewire devicecomprising: a micro-fabricated elongated outer member having an outersurface and an interior surface forming a lumen extending from aproximal end to a distal end; an outer elastomer laminate layer incontact with at least a portion of the outer surface; and an innermember disposed within a substantial portion of the lumen.

An aspect of the present embodiment is where the inner member is amonofilament wire core.

An aspect of the present embodiment is where the inner member is ahypotube.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member has a plurality of resultant beams, eachresultant beam formed between adjacent rings among a plurality of rings.

An aspect of the present embodiment is where the outer elastomerlaminate layer substantially covers all of the resultant beams.

An aspect of the present embodiment is where the outer elastomerlaminate layer covers completely all of the resultant beams.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member is formed from nitinol.

An aspect of the present embodiment is where the outer elastomerlaminate layer is formed from polyether block amide.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member is formed from a material having a modulus valueof about 3700 MPa.

An aspect of the present embodiment is where the outer elastomerlaminate layer is formed from a material having a modulus value of about12 MPa.

An aspect of the present embodiment is where the outer elastomerlaminate layer extends beyond the distal end to form a hollow distaltip.

An aspect of the present embodiment is where the hollow distal tipincludes a wire holding a shape for the hollow distal tip.

An aspect of the present embodiment is where the hollow distal tipincludes a radiopaque marker.

An embodiment of the present invention provides a guidewire devicecomprising a solid material micro-fabricated elongated outer memberhaving a plurality of resultant beams, each resultant beam formedbetween adjacent rings among a plurality of rings.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member is formed from nitinol.

An aspect of the present embodiment, further comprising an outerelastomer laminate layer covering at least a portion of the resultantbeams.

An aspect of the present embodiment is where the outer elastomerlaminate layer is formed from polyether block amide.

An aspect of the present embodiment is where the outer elastomerlaminate layer is formed from a material having a modulus value of about12 MPa.

An embodiment of the present invention provides a catheter devicecomprising: a micro-fabricated elongated outer member having an outersurface and an interior surface forming a lumen extending from aproximal end to a distal end, wherein the outer member is formed fromtwo or more different stock materials.

An aspect of the present embodiment, further comprising a torqueable hubconnected to the proximal end and having a barrel-shaped body with aplurality of longitudinal groves formed therein, and further forming anaxial interior space within which a syringe can be inserted.

An aspect of the present embodiment is where a first stock material ofthe two or more different stock materials is stainless steel.

An aspect of the present embodiment is where the stainless steel is usedat the proximal end.

An aspect of the present embodiment is where a second stock material ofthe two or more different stock materials is nitinol.

An aspect of the present embodiment is where the nitinol is used at theproximal end.

An aspect of the present embodiment, further comprising an outerelastomer laminate layer in contact with at least a portion of the outersurface.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member forms an interspersed skeleton and wherein theouter elastomer laminate layer forms a matrix of flexible material thatis disposed around the interspersed skeleton.

An aspect of the present embodiment is where the outer elastomerlaminate layer extends beyond the distal end to form a hollow distaltip.

An aspect of the present embodiment is where the hollow distal tipincludes a wire holding a shape for the hollow distal tip.

An aspect of the present embodiment is where the hollow distal tipincludes a radiopaque marker.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member further forms a plurality of fenestrations madethrough the outer surface and the interior surface into at least aportion of the lumen; and further comprising an outer elastomer laminatelayer in contact with at least a portion of the outer surface andfilling the plurality of fenestrations.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member forms an interspersed skeleton and wherein theouter elastomer laminate layer forms a matrix of flexible material thatis disposed around the interspersed skeleton.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member further forms a plurality of fenestrations madeat a distal portion of the outer member, and through the outer surfaceand the interior surface into at least a portion of the lumen; andfurther comprising an outer elastomer laminate layer in contact with atleast a portion of the outer surface and filling the plurality offenestrations.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member further forms a plurality of fenestrations madeat a proximal portion of the outer member, and through the outer surfaceand the interior surface into at least a portion of the lumen; andfurther comprising an outer elastomer laminate layer in contact with atleast a portion of the outer surface and filling the plurality offenestrations.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member has an outer diameter of the distal end that islarger than an outer diameter of the proximal end.

An embodiment of the present invention provides a guidewire devicecomprising: a micro-fabricated elongated outer member having an outersurface and an interior surface forming a lumen extending from aproximal end to a distal end, wherein the outer member is formed fromtwo or more stock materials; and an inner member disposed within aportion of the lumen.

An aspect of the present embodiment is where the inner member is amonofilament wire core.

An aspect of the present embodiment is where the inner member is ahypotube.

An aspect of the present embodiment is where a first stock material ofthe two or more different stock materials is stainless steel.

An aspect of the present embodiment is where the stainless steel is usedat the proximal end.

An aspect of the present embodiment is where a second stock material ofthe two or more different stock materials is nitinol.

An aspect of the present embodiment is where the nitinol is used at thedistal end.

An aspect of the present embodiment, further comprising an outerelastomer laminate layer in contact with at least a portion of the outersurface.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member further forms a plurality of fenestrations madethrough the outer surface and the interior surface into at least aportion of the lumen; and further comprising an outer elastomer laminatelayer in contact with at least a portion of the outer surface andfilling the plurality of fenestrations.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member forms an interspersed skeleton and wherein theouter elastomer laminate layer forms a matrix of flexible material thatis disposed around the interspersed skeleton.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member further forms a plurality of fenestrations madeat a distal portion of the outer member, and through the outer surfaceand the interior surface into at least a portion of the lumen; andfurther comprising an outer elastomer laminate layer in contact with atleast a portion of the outer surface and filling the plurality offenestrations.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member further comprises a plurality of fenestrationsmade at a proximal portion of the outer member, and through the outersurface and the interior surface into at least a portion of the lumen;and further comprising an outer elastomer laminate layer in contact withat least a portion of the outer surface and filling the plurality offenestrations.

An aspect of the present embodiment is where the micro-fabricatedelongated outer member has an outer diameter of the distal end that islarger than an outer diameter of the proximal end.

An embodiment of the present invention provides a catheter devicecomprising: an elongated outer member having an outer surface and aninterior surface forming a lumen extending from a proximal end to adistal end, wherein an outer diameter of the distal end is larger thanan outer diameter of the proximal end.

An aspect of the present embodiment is where the elongated outer memberis micro fabricated.

An aspect of the present embodiment is where the elongated outer memberis micro-fabricated at the distal portion.

An aspect of the present embodiment, further comprising an inner memberformed of a monofilament wire core, the inner member disposed within aportion of the lumen.

An aspect of the present embodiment, further comprising an inner memberformed of a hypotube, the inner member disposed within a portion of thelumen.

An aspect of the present embodiment, further comprising a torqueable hubconnected to the proximal end and having a barrel-shaped body with aplurality of longitudinal groves formed therein, and further forming anaxial interior space within which a syringe can be inserted.

An aspect of the present embodiment is where the outer diameter of theproximal end is about 0.030 inches.

An aspect of the present embodiment is where the outer diameter of thedistal end is about 0.039 inches.

An aspect of the present embodiment is where the outer diameter of theproximal end is about 0.030 inches, and the outer diameter of the distalend is about 0.039 inches.

An aspect of the present embodiment is where the lumen has an innerdiameter of about 0.024 inches.

An embodiment of the present invention provides a guidewire devicecomprising: an elongated outer member having an outer surface and aninterior surface forming a lumen extending from a proximal end to adistal end, wherein an outer diameter of the distal end is larger thanan outer diameter of the proximal end; and

an inner member disposed within a portion of the lumen.

An aspect of the present embodiment is where at least a portion of theelongated outer member is micro fabricated.

An aspect of the present embodiment is where the elongated outer memberis micro-fabricated at the distal portion.

An aspect of the present embodiment is where the inner member is amonofilament wire core.

An aspect of the present embodiment is where the inner member is ahypotube.

An aspect of the present embodiment, further comprising a torqueable hubconnected to the proximal end and having a barrel-shaped body with aplurality of longitudinal groves formed therein, and further forming anaxial interior space within which a syringe can be inserted.

An aspect of the present embodiment is where the outer diameter of theproximal end is about 0.030 inches.

An aspect of the present embodiment is where the outer diameter of thedistal end is about 0.039 inches.

An aspect of the present embodiment is where the outer diameter of theproximal end is about 0.030 inches, and the outer diameter of the distalend is about 0.039 inches.

An aspect of the present embodiment is where the lumen has an innerdiameter of about 0.024 inches.

While embodiments have been illustrated and described herein, it is tobe understood that the techniques described herein can have a multitudeof additional uses and applications. Accordingly, the invention shouldnot be limited to just the particular description and various drawingfigures contained in this specification that merely illustrate one ormore embodiments and application of the principles of the invention.

1. An intravascular device, comprising: an elongated member having aproximal portion and a distal portion, wherein the distal portionincludes an outer surface, an inner surface, and a plurality offenestrations formed therein, the fenestrations having a depth extendingbetween the outer surface and the inner surface, and the fenestrationsdefining a plurality of radially extending beams and axially extendingbeams; and an elastomeric filling material encapsulating the distalportion and filling the full depth of the fenestrations between theouter surface and the inner surface of the elongated member.
 2. Theintravascular device of claim 1, wherein an outer diameter of the distalportion of the elongated member is larger than an outer diameter of theproximal portion of the elongated member.
 3. The intravascular device ofclaim 2, wherein a length of the distal portion is up to 20% of a fulllength of the intravascular device.
 4. The intravascular device of claim1, further comprising an inner member disposed within at least a portionof a lumen of the elongated member.
 5. The intravascular device of claim4, wherein the inner member has a substantially constant diameter alongits length.
 6. The intravascular device of claim 4, wherein the innermember decreases in diameter from a proximal end toward a distal end. 7.The intravascular device of claim 1, wherein a lumen of the elongatedmember increases in diameter at the distal portion relative to at theproximal portion.
 8. The intravascular device of claim 1, wherein alumen of the elongated member has a continuous diameter.
 9. Theintravascular device of claim 1, wherein the monolithic elastomericfilling material provides fluid integrity in the elongated member. 10.The intravascular device of claim 1, wherein the proximal portion anddistal portion are formed from different materials.
 11. Theintravascular device of claim 1, wherein the fenestrations are arrangedin a rotating pattern along a longitudinal axis of the elongated member.12. The intravascular device of claim 11, wherein the rotating patternhas an angular variance of about 5 degrees to about 95 degrees.
 13. Theintravascular device of claim 1, wherein the elongated member is formedof a polymer.
 14. The intravascular device of claim 1, wherein theelongated member has a modulus of about 3700 MPa to about 138 GPa. 15.The intravascular device of claim 4, wherein the inner member is formedof stainless steel.
 16. The intravascular device of claim 1, wherein theelongated member is formed of nitinol.
 17. The intravascular device ofclaim 1, wherein the ratio of a modulus of the elongated member to amodulus of the elastomeric filling material is 7.4 to
 370. 18. Theintravascular device of claim 1, wherein the elastomeric fillingmaterial extends beyond a distal end of the elongated member to form ahollow distal tip.
 19. An intravascular device, comprising: an elongatedmember having a proximal portion and a distal portion, wherein at leastthe distal portion has a modulus of about 3700 MPa to about 138 GPa andincludes an outer surface, an inner surface, and a plurality offenestrations formed therein, the fenestrations having a depth extendingbetween the outer surface and the inner surface, and the fenestrationsdefining a plurality of radially extending beams and axially extendingbeams, wherein the fenestrations are arranged in a rotating patternalong a longitudinal axis of the elongated member; and an elastomericfilling material encapsulating the distal portion and filling the fulldepth of the fenestrations between the outer surface and the innersurface of the elongated member.
 20. An intravascular device,comprising: an elongated member having a proximal portion and a distalportion each formed from a different material, wherein the distalportion comprises nitinol and includes an outer surface, an innersurface, and a plurality of fenestrations formed therein, thefenestrations having a depth extending between the outer surface and theinner surface, and the fenestrations defining a plurality of radiallyextending beams and axially extending beams, wherein the fenestrationsare arranged in a rotating pattern along a longitudinal axis of theelongated member, and wherein the rotating pattern has an angularvariance of about 5 degrees to about 95 degrees; and a stainless steelinner member disposed within at least a portion of a lumen of theelongated member.